This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

Start Date31 Jan 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT06401330 / Not yet recruitingPhase 3IIT

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.

Start Date31 Dec 2024

Sponsor / Collaborator-

NCT06620302 / Not yet recruitingPhase 1/2IIT

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking BCL-XL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.

Start Date20 Dec 2024

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

100 Clinical Results associated with Irinotecan Hydrochloride

100 Translational Medicine associated with Irinotecan Hydrochloride

100 Patents (Medical) associated with Irinotecan Hydrochloride

11,669

Literatures (Medical) associated with Irinotecan Hydrochloride

01 Dec 2025·Journal of Gastrointestinal Cancer

Network Meta-analysis of Randomized Controlled Trials in Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: Comparisons Involving Ramucirumab

Review

Author: Taipale, Kaisa ; Paine, Abby ; Gupta, Palvi ; D'yachkova, Yulia ; Liepa, Astra M ; Earley-Valovic, Veronika ; Goel, Rajat

PURPOSE:

With relatively few direct comparisons among treatment options for previously treated advanced gastric cancer or gastroesophageal junction (GEJ) cancer, network meta-analysis (NMA) may inform evidence-based decision-making. Ramucirumab plus paclitaxel (RAM + PTX) is a preferred regimen in guideline recommendations. NMA of key outcomes may further characterize the relative clinical value of RAM + PTX.

METHODS:

A systematic literature review of randomized controlled trials of adult patients with previously treated advanced gastric/GEJ cancer informed a NMA which compared overall survival, progression-free survival, and discontinuations due to adverse events. Comparisons were reported relative to placebo/best supportive care (BSC) when possible, otherwise relative to RAM + PTX.

RESULTS:

The base-case NMA focused on second-line treatment only, from 19 of 28 studies identified. For overall survival, seven of 16 regimens were favorable relative to placebo/BSC, with RAM + PTX as the most favorable. For progression-free survival, five of 14 regimens were unfavorable relative to RAM + PTX. For discontinuations due to adverse events, two of 13 regimens were similar to placebo/BSC: ramucirumab monotherapy and fluorouracil; relative to RAM-PTX, all regimens were similar except ramucirumab monotherapy which was favorable and irinotecan + cisplatin which was unfavorable.

CONCLUSION:

This NMA of trials of previously treated gastric/GEJ cancer suggests that RAM + PTX has one of the more favorable clinical profiles.

31 Dec 2024·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective

Article

Author: Asfaw, Alemseged Ayele ; Hernandez, Luis ; Li, Shujun ; Zou, Denise ; Paly, Victoria Federico ; Khanduri, Pratishtha

AIMS:

Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare).

MATERIALS AND METHODS:

A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM).

RESULTS:

The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population.

CONCLUSIONS:

Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.

15 Dec 2024·INTERNATIONAL JOURNAL OF CANCER

A multicenter, prospective, phase II trial of second‐line aflibercept plus FOLFIRI in patients with metastatic colorectal cancer refractory to an anti‐EGFR antibody: HGCSG1801

Article

Author: Yoshikawa, Ayumu ; Dazai, Masayoshi ; Yuki, Satoshi ; Muranaka, Tetsuhito ; Sogabe, Susumu ; Sakata, Yu ; Takagi, Ryo ; Kotaka, Masahito ; Sagawa, Tamotsu ; Kawamoto, Yasuyuki ; Ando, Takayuki ; Nakamura, Michio ; Harada, Kazuaki ; Sasaki, Yusuke ; Hatanaka, Kazuteru ; Tateyama, Miki ; Komatsu, Yoshito ; Nakatsumi, Hiroshi ; Sawada, Kentaro ; Muto, Osamu ; Ishiguro, Atsushi

Abstract:

Aflibercept (AFL) plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer (mCRC). However, there is limited evidence on the efficacy and safety of AFL plus FOLFIRI previously treated with anti‐epidermal growth factor receptor (EGFR) agents. Therefore, we conducted a prospective open‐label phase II trial evaluating the efficacy and safety of AFL plus FOLFIRI in Japanese patients with mCRC failing a prior oxaliplatin‐based chemotherapy plus an anti‐EGFR agent. AFL (4 mg/kg iv) followed by FOLFIRI (irinotecan 180 mg/m2, leucovorin 200 mg/m2 iv, bolus 5‐fluorouracil [5‐FU] 400 mg/m2, and infusional 5‐FU 2400 mg/m2/46 h) was given every 2 weeks until progression or unacceptable toxicities. The primary endpoint was progression‐free survival (PFS) rate at 6 months. Forty three patients were enrolled between November 2019 and October 2022. The primary endpoint was met: 6‐month PFS rate was 58.8% (90% confidence interval [CI], 45.7%–72.0%). Median PFS and OS were 7.3 months (95% CI, 5.5–11.0 months) and 18.8 months (95% CI, 12.9–26.6 months), respectively. The overall response rate was 20.9% (95% CI, 10.0–36.0%) and disease control rate was 88.4% (95% CI, 74.9–96.1%). The main grade ≥3 adverse events included hypertension (62.8%), neutropenia (55.8%), leukopenia (25.6%), febrile neutropenia (11.6%), fatigue (9.3%), anorexia (9.3%), proteinuria (9.3%), and diarrhea (7.0%). No deaths and no new safety signals with a causal relation to the study treatment were observed. This study suggests that AFL plus FOLFIRI shows a high response rate and a manageable safety profile in Japanese patients with mCRC who failed prior oxaliplatin‐based chemotherapy plus an anti‐EGFR agent.

365

News (Medical) associated with Irinotecan Hydrochloride

30 Oct 2024

·www.globenewswire.com

Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results

First patient dosed in Phase 2 clinical trial with NGC-Cap for metastatic breast cancer Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde® HANOVER, Md., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and nine months ended September 30, 2024. “We continued to make progress with our programs as we further demonstrate the potential benefits of our oncology therapeutics,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is underway with the first patient dosed. As this is an open-label trial, we anticipate sharing initial data in the second half of 2025. Additionally, we reported positive findings from preclinical studies that support NGC-Iri’s potential for improved efficacy and a superior side effect profile compared with the commonly used FDA-approved chemotherapy drugs irinotecan and Onivyde®. We are pleased with our progress and remain committed to improving the lives of people with cancer.” Key Program UpdatesProcessa is focused on developing next-generation chemotherapies (NGC) by improving widely used U.S. Food and Drug Administration (FDA)-approved drugs to extend cancer patients’ survival and/or improve their quality of life. This is achieved by altering how drugs are metabolized and/or distributed in the body, including how they reach cancer cells. In addition, Processa utilizes its Regulatory Science Approach, including the principles associated with FDA’s Project Optimus Oncology initiative, in the development of its NGC drug products to achieve a more favorable benefit-risk profile. PCS6422: Next-Generation Capecitabine (NGC-Cap) NGC-Cap is a combination of PCS6422 and capecitabine, which is the oral prodrug of the cancer drug 5-fluorouracil (5-FU). PCS6422 alters the metabolism of 5-FU, resulting in more 5-FU distributed to cancer cells.Earlier this month, the first patient was dosed in a Phase 2 clinical trial (NCT06568692) evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. The Phase 2 study is a global, multicenter, open-label, adaptive-design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. The Company expects to announce interim data from this trial in the second half of 2025. PCS3117: Next-Generation Gemcitabine (NGC-Gem) NGC-Gem is an oral analog of gemcitabine (Gemzar®) that is converted to its active metabolite by a different enzyme system, with potential for a positive response in gemcitabine patients including those inherently resistant to or who acquire resistance to gemcitabine.Processa is evaluating the potential of NGC-Gem in patients with pancreatic and other cancers, as well as ways to identify patients who are more likely to respond to NGC-Gem than gemcitabine alone. The Company is requesting a meeting with the FDA to discuss potential trial designs, including implementation of the Project Optimus initiative. PCS11T: Next-Generation Irinotecan (NGC-Iri) NGC-Iri is an analog of SN-38, the active metabolite of irinotecan, that is expected to have an improved safety-efficacy profile in every type of cancer where irinotecan is currently used.As announced in August, two studies in a human melanoma xenograft mouse model measured SN-38 in tumors, plasma and other tissues following administration of NGC-Iri, irinotecan and Onivyde®, the liposomal formulation of irinotecan. One study compared NGC-Iri with irinotecan, and the other compared irinotecan with Onivyde®. The results found that mice administered NGC-Iri had greater accumulation of SN-38 in the tumor compared with other tissues and that less SN-38 accumulated in non-cancer tissues, which could lead to improved efficacy with a more favorable adverse event profile compared with irinotecan and Onivyde®.The Company is currently evaluating the manufacturing process and potential sites for NGC-Iri. In addition, Processa is defining the potential paths to approval, which includes defining the target patient population and the type of cancer, and expects to conduct IND-enabling toxicology studies in 2025. Third Quarter Financial Results Research and development expenses for the third quarter of 2024 were $2.3 million, compared with $1.2 million for the third quarter of 2023. General and administrative expenses for the third quarter of 2024 were $1.1 million, compared with $1.0 million for the third quarter of 2023. The net loss for the third quarter of 2024 was $3.4 million, or $1.03 per share, compared with the net loss for the third quarter of 2023 of $2.1 million, or $1.54 per share. All per-share figures reflect a 1-for-20 reverse stock split that was effective as of January 22, 2024. Cash and cash equivalents were $2.9 million as of September 30, 2024. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations Contact:Yvonne BriggsAlliance Advisors Investor Relations(310) 691-7100ybriggs@allianceadvisorsir.com [Financial Tables to follow]PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share information) (unaudited) September 30, 2024 December 31, 2023 ASSETS Current Assets Cash and cash equivalents $2,891 $4,706 Prepaid expenses and other 1,947 926 Total Current Assets 4,838 5,632 Property and Equipment, net 5 3 Other Assets Lease right-of-use assets, net of accumulated amortization 93 146 Security deposit 6 6 Total Other Assets 99 152 Total Assets $4,942 $5,787 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Current maturities of lease liabilities $94 $84 Accounts payable 712 312 Due to licensor - 189 Due to related parties - - Accrued expenses 413 146 Total Current Liabilities 1,219 731 Non-current Liabilities Non-current lease liabilities 2 67 Total Liabilities 1,221 798 Commitments and Contingencies - - Stockholders’ Equity Common stock, par value $0.0001, 100,000,000 shares authorized: 3,271,944 issued and 3,266,944 outstanding at September 30, 2024; and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 - - Additional paid-in capital 88,511 80,658 Treasury stock at cost — 5,000 shares at September 30, 2024 and December 31, 2023 (300) (300)Accumulated deficit (84,490) (75,369)Total Stockholders’ Equity 3,721 4,989 Total Liabilities and Stockholders’ Equity $4,942 $5,787 PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share data)(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating Expenses Research and development $2,288 $1,152 $5,557 $4,479 General and administrative 1,137 1,016 3,760 4,509 Operating Loss (3,425) (2,168) (9,317) (8,988) Other Income (Expense) Interest income, net 40 86 195 271 Net Loss $(3,385) $(2,082) $(9,122) $(8,717) Net Loss per Common Share - Basic and Diluted $(1.03) $(1.54) $(3.13) $(6.81) Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted 3,275,998 1,350,188 2,909,941 1,279,298 # # #

Phase 2Financial StatementClinical ResultPhase 1

16 Oct 2024

·www.biospace.com

Jazz Touts Survival Benefit for First-Line Maintenance Therapy in SCLC

iStock, Chinnapong Jazz Pharmaceuticals contends that its alkylating agent Zepzelca significantly improved both overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, when used as a front-line maintenance therapy with Roche’s Tecentriq. Jazz on Tuesday unveiled topline findings from the Phase III IMforte study, demonstrating that its intravenous drug Zepzelca, when given with Roche’s Tecentriq, can significantly boost survival as a first-line maintenance therapy in patients with extensive-stage small cell lung cancer. The company did not provide specific data in its announcement, noting only that the Zepzelca-based combo regimen elicited a “statistically significant improvement” in overall survival and progression-free survival—both primary endpoints of IMforte—compared with Tecentriq alone. In terms of safety, IMforte found the Zepzelca combo to be generally well-tolerated, with an adverse event pro with that of the known toxicities of the individual agents. There were no new signals of concern detected, according to the company. Jazz CMO Rob Iannone in a statement called the results “highly encouraging,” noting that they also “demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease.” The company will use IMforte’s data to support a supplemental New Drug Application for Zepzelca, which it plans to the first half of 2025 in the pursuit of a first-line maintenance expansion for the drug. Jazz and partner Roche will also submit IMforte’s data for presentation at an upcoming medical congress. Zepzelca is an intravenously administered alkylating drug that works by binding to and bending the DNA, restricting the replication and repair of genetic material and ultimately leading to cell death. This mechanism of action allows Zepzelca to target and eventually destroy cancer cells. The FDA first approved Zepzelca in June 2020 under its accelerated pathway, allowing the use of the drug for the treatment of metastatic small cell lung cancer (SCLC) patients who had progressed on or after platinum chemotherapy. As part of its obligations under the accelerated pathway, Jazz ran the Phase III ATLANTIS trial to serve as Zepzelca’s confirmatory study but announced in December 2020 that the drug fell short of its primary endpoint . Still, in October 2022, the FDA decided to uphold Zepzelca’s accelerated approval, noting that dosing differences in ATLANTIS—which used a lower dose—could likely be the reason why it failed. The FDA’s decision also came despite a citizen petition from law firm Foley Hoag, asking the regulator to pull its approval of Zepzelca. IMforte is one of two trials that Jazz is running in place of ATLANTIS, which are in line with its discussions with the FDA. The second study is dubbed LAGOON , which launched in 2022 and will test the approved dose of Zepzelca as a monotherapy, as well as a lower Zepzelca dose combined with irinotecan.

Phase 3Clinical ResultDrug ApprovalAccelerated Approval

04 Oct 2024

·www.globenewswire.com

Onco360® Has Been Selected as The National Specialty Pharmacy Partner for Tevimbra® (tislelizumab-jsgr)

LOUISVILLE, Ky., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Beigene for Tevimbra® (tislelizumab), approved for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. This indication was approved based on the Phase III RATIONALE-302, (NCT03430843) clinical trial, which compared Tislelizumab to systemic chemotherapy.1 Tevimbra® (tislelizumab) is a PD-1 inhibitor that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response. Esophageal cancer (EC) is the sixth most common cause of cancer-related deaths. ESCC is the most common histologic subtype of EC, accounting for nearly 90% of ECs. Esophageal cancer is a rapidly fatal disease. Over two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.2 “Onco360 is grateful for the opportunity to expand our partnership with the team at BeiGene and become the exclusive national specialty pharmacy provider for Tevimbra®,” said Benito Fernandez. “The FDA approval of Tevimbra represents a new treatment option for patients suffering from unresectable or metastatic esophageal cancer, and as a chosen provider, we remain committed to providing patients, their caregivers, and providers with the highest level of quality and service.” The FDA approval of Tevimbra® is based on the results of the Phase III RATIONALE-2 clinical trial, which evaluated 512 adult patients with unresectable advanced or metastatic esophageal (ESCC), randomized 1:1 to receive Tevimbra® 200mg IV every 3 weeks or investigator’s choice IV systemic chemotherapy (paclitaxel, docetaxel, or irinotecan). All patients had received at least one prior anti-cancer systemic therapy. RATIONALE-302 demonstrated a statistically significant improvement in overall survival (OS) for patients randomized to Tevimbra® as compared with systemic chemotherapy. The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased glucose (46%), decreased hemoglobin (45%), decreased lymphocytes (43%), decreased sodium (34%), decreased albumin (33%), increased alkaline phosphatase (32%), anemia (31%), fatigue (28%), increased AST (27%), musculoskeletal pain (24%), decreased weight (23%), increased ALT (23%), and cough (22%). Please see the full Prescribing Information for Tevimbra® About Onco360 Oncology Pharmacy:Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com. Media Contact: Benito Fernandez, Chief Commercial OfficerBenito.Fernandez@Onco360.com516-640-1332 References: Lin Shen et al., RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma. JCO 39, 4012-4012(2021). National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Irinotecan Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01061	Irinotecan Hydrochloride	L01XX19	DBSALT000103

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	AU	SERVIER LABORATORIES (AUST.) PTY. LTD.	06 Mar 2024
Pancreatic Carcinoma	JP	Daiichi Sankyo Co., Ltd.	20 Dec 2013
Childhood Malignant Solid Neoplasm	JP	Yakult Honsha Co., Ltd.	25 Mar 2013
Childhood Malignant Solid Neoplasm	JP	Daiichi Sankyo Co., Ltd.	25 Mar 2013
Intestinal Neoplasms	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 1998
Colonic Cancer	US	Pfizer Inc.	14 Jun 1996
Rectal Cancer	US	Pfizer Inc.	14 Jun 1996
Breast Cancer	JP	Alfresa Pharma Corp.	29 Sep 1995
Breast Cancer	JP	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Breast Cancer	JP	Yakult Honsha Co., Ltd.	29 Sep 1995
Colorectal Cancer	JP	Yakult Honsha Co., Ltd.	29 Sep 1995
Colorectal Cancer	JP	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Colorectal Cancer	JP	Alfresa Pharma Corp.	29 Sep 1995
Non-Hodgkin Lymphoma	JP	Yakult Honsha Co., Ltd.	29 Sep 1995
Non-Hodgkin Lymphoma	JP	Alfresa Pharma Corp.	29 Sep 1995
Non-Hodgkin Lymphoma	JP	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Squamous Cell Carcinoma	JP	Alfresa Pharma Corp.	29 Sep 1995
Squamous Cell Carcinoma	JP	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Squamous Cell Carcinoma	JP	Yakult Honsha Co., Ltd.	29 Sep 1995
Stomach Cancer	JP	Alfresa Pharma Corp.	29 Sep 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Small cell lung cancer recurrent	Phase 3	CN	Luye Pharma Group Ltd.	03 Mar 2024
Esophageal Carcinoma	Phase 3	CA	Pfizer Inc.	01 Apr 2009
Metastatic colon cancer	Phase 3	US	Bristol Myers Squibb Co.	01 Dec 2003
Metastatic colon cancer	Phase 3	US	Eli Lilly & Co.	01 Dec 2003
Rectal Adenocarcinoma	Phase 3	US	Eli Lilly & Co.	01 Dec 2003
Rectal Adenocarcinoma	Phase 3	US	Bristol Myers Squibb Co.	01 Dec 2003
Unknown Primary Neoplasms	Phase 3	US	Pharmacia & Upjohn, Inc.	01 Sep 2003
Unknown Primary Neoplasms	Phase 3	US	Eli Lilly & Co.	01 Sep 2003
Unknown Primary Neoplasms	Phase 3	US	AstraZeneca PLC	01 Sep 2003
EGFR Positive Cancer	Phase 3	US	Eli Lilly & Co.	01 Apr 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04117945 (CTgov)	Phase 2	Colorectal Cancer, Hereditary Nonpolyposis, Type 1 \| Metastatic Colorectal Carcinoma	22	Regorafenib (Arm A (Regorafenib))	uetqbmnlcv(hrfbzdgeou) = dmbzrgrnit knyyoqmdvn (cgxdsvofpj, oiygbujpoi - wkszqdnlav) View more	-	27 Sep 2024
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	uetqbmnlcv(hrfbzdgeou) = ctppfdaoxw knyyoqmdvn (cgxdsvofpj, sqterujhhl - uzqjlgfynw) View more
NCT03483038 (NEO-Nal-IRI, CTgov)	Phase 2	Pancreatic adenocarcinoma	45	LEUCOVORIN CALCIUM+Liposomal Irinotecan+Oxaliplatin+Fluorouracil	lizrowdrmw(yoqxvcxads) = swijuamuth euezwpzotf (weqmbknkie, oypyohndcf - dzamsheqtd) View more	-	23 Sep 2024
EUCTR2019-000922-23-DE (IRITACE, ESMO2024) Manual	Phase 2	Hepatocellular Carcinoma	20	DEB-TACE with Irinotecan and Mitomycin C	lpaasodbgc(owpgdjucsn) = gikzgrhcoe siwtfzeobl (fmoarykqhm ) View more	Negative	16 Sep 2024
				DEB-TACE with Doxorubicin	lpaasodbgc(owpgdjucsn) = grstmcuaet siwtfzeobl (fmoarykqhm ) View more
NCT02605265 (CinClare, ESMO2024)	Phase 3	Locally Advanced Rectal Carcinoma	356	Capecitabine only	dazxtbvzxk(phqhsvwtel) = rkfxuoaypo ypboybzfgp (zcvyamgtlw ) View more	Positive	16 Sep 2024
				1-3 cycles of weekly irinotecan	dazxtbvzxk(phqhsvwtel) = ibmznzbmgm ypboybzfgp (zcvyamgtlw ) View more
CITRIC (ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma	114	Cetuximab and irinotecan	dpcvneecjr(rlqagqrmei) = bzggmkhepx ijrsnfoqbf (tzcjfulcoh ) View more	Positive	14 Sep 2024
				Investigator's choice (excluding anti-EGFR)	dpcvneecjr(rlqagqrmei) = vjfcyultfa ijrsnfoqbf (tzcjfulcoh ) View more
NCT05153239 (LAGOON, ESMO2024) Manual	Phase 2	Small cell lung cancer recurrent Second line	101	Lurbinectedin 2.0 mg/m^2 + Irinotecan 75 mg/m^2 (All pts with CTFI>30)	kxegqvglte(vajbtcctci) = edmexucdfk fagkarihfz (buyrrpstmf, 9.1 - 14.1) View more	Positive	14 Sep 2024
				Lurbinectedin 2.0 mg/m^2 + Irinotecan 75 mg/m^2 (CTFI 30-90 d)	kxegqvglte(vajbtcctci) = evizeuummt fagkarihfz (buyrrpstmf, 3.7 - 13.6) View more
JPRN-jRCTs031180216 (JCOG1205/1206, ESMO2024) Manual	Phase 3	Neuroendocrine neoplasm of lung	221	Etoposide/cisplatin (EP)	lzsbvlyqnl(yythxrhwny) = xqlkvgnjwq krcvbvmfbb (ijhjegocav ) View more	Negative	14 Sep 2024
				Irinotecan/cisplatin (IP)	lzsbvlyqnl(yythxrhwny) = itrenghhiu krcvbvmfbb (ijhjegocav ) View more
NCT03053167 (Pubmed \| BMC Cancer) Manual	Phase 2	Colorectal Cancer Second line	108	Raltitrexed+Irinotecan	thhdojmiif(hgmbefiyos) = yjmptekhez xzjgrfkynu (pxhudmshlw, 4.1 - 5.7) View more	Positive	02 Sep 2024
NCT01595321 (CTgov)	Phase 2	Pancreatic adenocarcinoma	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	swgowsnqew(idhuzeqamu) = vfudlymsex abkjhdkqkh (xqdqqqdjbp, hfbeazohwq - vhqjslcmvo) View more	-	14 Aug 2024
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	swgowsnqew(idhuzeqamu) = vtnshizfpp abkjhdkqkh (xqdqqqdjbp, msgchbpzdm - ladfpolcsf) View more
NCT02842580 (HIGH-LIGHT, CTgov)	Phase 2	Metastatic Colorectal Carcinoma	21	acide folinique+Bevacizumab+irinotecan+Oxaliplatin+capécitabine+5FU (Standard Arm (Escalation Strategy - Arm A))	yoxqzapgye(bdbokusott) = zyrgjjadhv cfdagyieuh (cuggpgbctz, drshvksedn - ufssirhloh) View more	-	10 Jul 2024
				acide folinique+Bevacizumab+irinotecan+Oxaliplatin+capécitabine+5FU (Experimental Arm (De-escalation Strategy -Arm B))	yoxqzapgye(bdbokusott) = ihhomanzwh cfdagyieuh (cuggpgbctz, rpqgjcieco - savvrbvgmh) View more

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