A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

Start Date01 Jan 2024

Sponsor / Collaborator

Celcuity, Inc.

NCT05501886 / RecruitingPhase 3

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Start Date30 Sep 2022

Sponsor / Collaborator

Celcuity, Inc.

NCT03698383 / Unknown statusPhase 2

Phase II Study of Trastuzumab Biosimilar (Herzuma®) Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer Who Progressed After 2 or More HER-2 Directed Chemotherapy

Phase II Pilot Study of Trastuzumab Biosimilar (Herzuma®) plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy

Start Date03 Dec 2019

Sponsor / Collaborator

Korean Cancer Study Group

100 Clinical Results associated with Gedatolisib

100 Translational Medicine associated with Gedatolisib

100 Patents (Medical) associated with Gedatolisib

Literatures (Medical) associated with Gedatolisib

01 Apr 2024·The Lancet Oncology

Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study

Article

Author: Kabos, Peter ; Rugo, Hope S ; Gorbatchevsky, Igor ; Specht, Jennifer M ; Wesolowski, Robert ; Stringer-Reasor, Erica M ; Layman, Rachel M ; Suzuki, Samuel ; Han, Hyo S ; Dees, E Claire ; Mutka, Sarah C ; Sullivan, Brian F

BACKGROUNDThe PI3K-mTOR pathway is frequently dysregulated in breast cancer. Combining an inhibitor targeting all class I PI3K isoforms and mTOR complex 1 (mTORC1)-mTOR complex 2 (mTORC2) with endocrine therapy and a CDK4/6 inhibitor might provide more effective tumour control than standard-of-care therapy. To evaluate this hypothesis, gedatolisib, a pan-PI3K-mTOR inhibitor, was assessed in a phase 1b trial combined with palbociclib and endocrine therapy in patients with hormone receptor-positive, HER2-negative, advanced breast cancer. Results from the dose expansion portion of this trial are reported herein.METHODSThis multicentre, open-label, phase 1b study recruited female patients aged at least 18 years from 17 sites across the USA with hormone-receptor-positive, HER2-negative, advanced breast cancer and an Eastern Cooperative Oncology Group performance status of 0-1. Four patient groups were studied in the dose expansion portion of the study: treatment-naive in the advanced setting (first line; group A), progression on 1-2 lines of endocrine therapy but CDK4/6 inhibitor-naive (group B); and one or more previous lines (second-line and higher) of therapy, including a CDK4/6 inhibitor (groups C and D). Gedatolisib 180 mg was administered intravenously weekly in 28-day treatment cycles for groups A-C, and on days 1, 8, and 15 for group D. Letrozole (group A), fulvestrant (groups B-D), and palbociclib (all groups) were administered at standard doses and schedules. The primary endpoint was investigator-assessed objective response rate per RECIST version 1.1 in the evaluable analysis set. This trial is completed and registered with ClinicalTrials.gov, NCT02684032.FINDINGSBetween Dec 19, 2017, and June 19, 2019, 103 female participants were enrolled in the dose expansion groups A (n=31), B (n=13), C (n=32), and D (n=27). Median follow-up was 16·6 months (IQR 5·7-48·4) for group A, 11·0 months (7·6-16·9) for group B, 3·6 months (1·8-7·5) for group C, and 9·4 months (5·3-16·7) for group D for the primary endpoint. Gedatolisib, palbociclib, and endocrine therapy induced an objective response in 23 (85·2%; 90% CI 69·2-94·8) of 27 evaluable first-line participants (group A). In the second-line and higher setting, an objective response was observed in eight (61·5%; 90% CI 35·5-83·4) of 13 evaluable group B participants, seven (25·0%; 12·4-41·9) of 28 evaluable group C participants, and 15 (55·6%; 38·2-72·0) of 27 evaluable group D participants; this included participants with both wild-type and mutated PIK3CA tumours. The most common grade 3-4 treatment-related adverse events were neutropenia (65 [63%] of 103), stomatitis (28 [27%]), and rash (21 [20%]). Grade 3-4 hyperglycaemia was reported in six (6%) participants. 23 (22%) of 103 participants had a treatment-related serious adverse event, and there were no treatment-related deaths. Nine (9%) participants discontinued treatment because of a treatment-emergent adverse event.INTERPRETATIONGedatolisib plus palbociclib and endocrine therapy showed a promising objective response rate compared with the published results for standard-of-care therapies and had an acceptable safety profile.FUNDINGPfizer and Celcuity.

01 Jan 2024·Cancer Control

A Long Way to Go: A Scenario for Clinical Trials of PI3K Inhibitors in Treating Cancer

Article

Author: Trigueiros, Bárbara Adriana Ferreira Dos Santos ; Pimenta, Fabricia Pires ; Ávila, Andréa Rodrigues ; Santos, Ivan José Santana

Background Alterations in PI3K function are directly related to cancer, making PI3K inhibitors suitable options for anticancer therapies. Information on therapy using different types of PI3K inhibitors is available in literature, providing indications of trends in developing new therapies. Although some studies on PI3K inhibitors for cancer treatment provide clinical evidence, they do not allow a careful search for potential PI3K inhibitors conducted by development indicators. Here, we performed a foresight study of clinical trials involving PI3K inhibitors from the past 11 years using indicators of clinical evolution to identify technological trends and provide data for supporting recommendations for new study designs. Methods A comprehensive foresight study was designed based on documents from clinical trials on PI3K inhibitors to perform a systematic and comparative analysis, in order to identify technological trends on new cancer therapies. Results Our results demonstrate that total number of clinical trials has decreased over the years and, currently, there is a clear prevalence of studies using isoform-specific inhibitors in combined interventions. Clinical trials in Phases I and II were the most frequently found in the database, whereas Phase III trials correspond to 7% of studies. The measurement of clinical trials progression using indicators (drugs in Phase III profile, top-10 drugs, and top-10 combined drugs) demonstrated that the 3 new medicines BKM120, IBI-376, and PF-05212384 have a high potential to provide more efficient cancer treatment in combined interventions. These data also include the groups of targets for each drug, providing a useful and reliable source for design new combinations to overcome the resistance and the poor tolerability observed in some PI3K therapies. Conclusions The establishment of development indicators based on clinical trials for cancer treatment was useful to highlight the clinical investment in 3 new PI3K drugs and the advantages of combine therapy using FDA-approved drugs.

31 Dec 2023·Cancer Biology & Therapy

Preclinical evaluation of the CDK4/6 inhibitor palbociclib in combination with a PI3K or MEK inhibitor in colorectal cancer

Article

Author: Madden, Stephen ; Cremona, Mattia ; O'Neill, Brian ; Aslam, Razia ; Kennedy, Sean ; Lee, Cha Len ; Hennessy, Bryan T ; Farrelly, Angela ; Workman, Julie A ; Toomey, Sinead ; Carr, Aoife

BACKGROUNDStudies have demonstrated the efficacy of Palbociclib (CDK 4/6 inhibitor), Gedatolisib (PI3K/mTOR dual inhibitor) and PD0325901 (MEK1/2 inhibitor) in colorectal cancer (CRC), however single agent therapeutics are often limited by the development of resistance.METHODSWe compared the anti-proliferative effects of the combination of Gedatolisib and Palbociclib and Gedatolisib and PD0325901 in five CRC cell lines with varying mutational background and tested their combinations on total and phosphoprotein levels of signaling pathway proteins.RESULTSThe combination of Palbociclib and Gedatolisib was superior to the combination of Palbociclib and PD0325901. The combination of Palbociclib and Gedatolisib had synergistic anti-proliferative effects in all cell lines tested [CI range: 0.11-0.69] and resulted in the suppression of S6rp (S240/244), without AKT reactivation. The combination of Palbociclib and Gedatolisib increased BAX and Bcl-2 levels in PIK3CA mutated cell lines. The combination of Palbociclib and Gedatolisib caused MAPK/ERK reactivation, as seen by an increase in expression of total EGFR, regardless of the mutational status of the cells.CONCLUSIONThis study shows that the combination of Palbociclib and Gedatolisib has synergistic anti-proliferative effects in both wild-type and mutated CRC cell lines. Separately, the phosphorylation of S6rp may be a promising biomarker of responsiveness to this combination.

News (Medical) associated with Gedatolisib

08 May 2024

·www.globenewswire.com

Celcuity Inc. Schedules Release of First Quarter 2024 Financial Results and Webcast/Conference Call

MINNEAPOLIS, May 08, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2024 after the market closes on Wednesday, May 15, 2024. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-888-886-7786 and international callers should dial 1-416-764-8658. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1664947&tp_key=8c4820dec8. A replay of the webcast will be available on the Celcuity website following the live event.About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. The company's CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter. View source version of release on GlobeNewswire.com Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 ICR Westwicke Maria Yonkoski, maria.yonkoski@westwicke.com (203) 682-7167

Financial StatementPhase 3

03 May 2024

·www.prnewswire.com

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN). Since receiving Fast Track Designation from the FDA in late 2022 for its leading cancer treatment, pelareorep, in the treatment of pancreatic cancer, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has maintained strong progress. The company recently announced that it has requested a Type C meeting with the FDA to discuss an upcoming registration-enabling trial of pelareorep for treating HR+/HER2- metastatic breast cancer (mBC) patients. "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics. "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration." Dr. Coffey has noted that ongoing collaborations with clinical collaborators have been key to preparing a comprehensive and convincing briefing document. Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer. This meeting is essential for moving this promising treatment closer to patient use. With forthcoming survival data from its BRACELET-1 study and productive discussions with the FDA, Oncolytics is hopeful that 2024 will mark a significant milestone for the company and its stakeholders. "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients." Another company that's developing targeted therapies for multiple cancer indications is Celcuity Inc. (NASDAQ: CELC). Within its latest Q4/FY 2023 financial results and corporate update, Celcuity spoke of how it had dosed its first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration-resistant prostate cancer. "We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer," said Igor Gorbatchevsky, M.D., Chief Medical Officer of Celcuity. "A significant unmet need remains for patients with metastatic castration-resistant prostate cancer who have become resistant to a next generation androgen receptor inhibitor." Late last year, Celcuity also presented preclinical data on the therapeutic effects of gedatolisib in breast cancer models at the 2023 San Antonio Breast Cancer Symposium. As its flagship asset, Celcuity's gedatolisib is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. In the process of becoming an impressive comeback story, Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has moved from making job cuts in 2023 to moving forward with pivotal drug studies in 2024. Recently in March, Olema announced the publication of data highlighting its proprietary treatment palazestrant's (OP-1250) ability to inhibit wild-type and mutant ER+ breast cancer both as monotherapy and in combination with CDK4/6 inhibitors through a paper titled "Palazestrant (OP-1250), a Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination." "The research described in this paper reviews the deliberate design and processes used in discovering and optimizing palazestrant as a molecule purpose-built to address a crucial unmet need in the treatment of women's cancers, and we are delighted that Molecular Cancer Therapeutics has featured our work," said David C. Myles, Ph.D., Olema's Chief Discovery and Non-Clinical Development Officer. "What's even more exciting is to see how faithfully the pre-clinical research predicted the behavior of palazestrant now that it is in late-stage clinical development. We saw the potential then, as told in the paper, and we believe that every day brings us closer to having a real impact transforming the treatment paradigm for women with cancer." Helping to potentially detect breast cancer more easily, Bio-Rad Laboratories, Inc. (NYSE: BIO) recently launched its first ultrasensitive multiplexed digital PCR assay for breast cancer mutation detection in clinical research. The newly launched ddPLEX ESR1 Mutation Detection Kit assay expands Bio-Rad's Droplet Digital PCR (ddPCR™) offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring. "With the ddPLEX ESR1 Mutation Detection Kit, our customers can achieve new levels of sensitivity and multiplexing without compromising throughput," said Stephen Kulisch, Vice President of Marketing for Bio-Rad's Digital Biology Group. "This launch reflects our ongoing menu expansion in oncology and our commitment to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials that support improvements in patient monitoring." Shortly after the launch, Bio-Rad partnered with Alleghany Health Network (AHN) to advance clinical evidence for monitoring solid tumor cancers using the ddPCR technology. The collaboration will use ddPCR technology for molecular residual disease (MRD) monitoring of patients across a range of solid tumor types. Even more promising breast cancer data has come out recently from AstraZeneca PLC (NASDAQ: AZN) and partners Daiichi Sankyo for their jointly developed antibody drug conjugate Enhertu (trastuzumab deruxtecan), from their phase 3 breast cancer trial. Results from the DESTINY-Breast06 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy. "DESTINY-Breast06 shows that ENHERTU could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Clinical ResultPhase 2Fast Track

04 Apr 2024

·www.globenewswire.com

Celcuity To Present at Upcoming Needham and Stifel Investor Conferences

MINNEAPOLIS, April 04, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the 23rd Annual Needham Virtual Healthcare Conference at 2:15 p.m. ET on Thursday, April 11, 2024. A live webcast will be available using this weblink: https://wsw.com/webcast/needham138/celc/2214082; andA fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum at 10:00 a.m. ET on Wednesday, April 17, 2024. A live webcast will be available using this weblink: https://wsw.com/webcast/stifel92/celc/2056478. Alternatively, the live webcasts will be accessible from the Investors section of the company's website at https://ir.celcuity.com/events-presentations/ with a replay available shortly after the live events. About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. The company's CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter. View source version of release on GlobeNewswire.com Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 ICR Westwicke Maria Yonkoski, maria.yonkoski@westwicke.com (203) 682-7167

Phase 3

100 Deals associated with Gedatolisib

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KEGG	Wiki	ATC	Drug Bank
D10635	-	-	DB11896

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	DE	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	CA	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	HU	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	IT	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	RO	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	BR	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	ES	Celcuity, Inc.	30 Sep 2022
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	CZ	Celcuity, Inc.	30 Sep 2022
Hormone receptor positive HER2 negative breast cancer	Phase 3	US	Pfizer Inc.	23 Mar 2022
Acute Myeloid Leukemia	Phase 1	FR	Pfizer Inc.	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02684032 (B2151009, ASCO2018) Manual	Phase 1	ER-positive/HER2-negative Breast Cancer First line ER Positive \| HER2 Negative	35	letrozole+gedatolisib+palbociclib	(dttyiagnog) = czhskkmunn uvemavsvfn (ulyqyydsye ) View more	Positive	02 Jun 2018
NCT02684032 (B2151009, ASCO2018) Manual	Phase 1		35	fulvestrant+gedatolisib+palbociclib	(dttyiagnog) = olpgwcdggf uvemavsvfn (ulyqyydsye ) View more	Positive	02 Jun 2018
VIKTORIA-1 (SABCS2023)	Phase 3	Hormone receptor positive HER2 negative breast cancer PIK3CA mutation	-	gedatolisib plus palbociclib and fulvestrant	(vienphyzbx) = hyperglycemia of any grade occurred in 26% of patients meyhuqkdhr (fpsvkeehyu )	-	05 Dec 2023
NCT01920061 (ASCO2016) Manual	Phase 1	Solid tumor	74	docetaxel+gedatolisib (PC,BC or NSCLC)	(hsxdoqvbqo) = Cycle 1 dose limiting toxicities (DLTs) were: A: grade 3 mucositis (n = 1);B: no DLT;C: grade 3 mucositis (n = 1), pneumonitis (n = 1), rash (n = 1), and grade 2 fatigue (n = 1). PK parameters for G were similar regardless of combination agent. fhmvtbokag (tzbsgduoni ) View more	Positive	05 Jun 2016
NCT01920061 (ASCO2016) Manual	Phase 1	Solid tumor	74	cisplatin+gedatolisib (TCC,TNBC NSCLC or ovarian cancer)		Positive	05 Jun 2016
NCT00940498 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Advanced cancer	78	PKI-587	(exghhhmnwq) = dxtqdjkydw vgiynipowb (onlfoxutar ) View more	Positive	15 Apr 2015
VIKTORIA-1 (SABCS2022)	Phase 3	Hormone receptor positive HER2 negative breast cancer PIK3CA mutation	-	gedatolisib plus palbociclib and fulvestrant	(tqlfiotgnf) = hyperglycemia of any grade occurred in 26% of patients wadcsvsmot (niwddbuliq )	-	06 Dec 2022
NCT03911973 (ASCO2022) Manual	Phase 1/2	Germline BRCA-mutated, HER2-negative metastatic breast cancer \| Triple Negative Breast Cancer Second line BRCA1 Mutation \| HER2 Negative \| ER Negative ... View more	14	Gedatolisib+Talazoparib	(cpozdgwnsa) = The MTD of gedatolisib was 180 mg and MTD of talazoparib was 1 mg. lqrrqiqmaa (mvnhqwhfiu ) View more	Positive	02 Jun 2022
NCT03911973 (ASCO2022) Manual	Phase 1/2		14	Gedatolisib+Talazoparib (patients with a BRCA 1 or 2 mutation)		Positive	02 Jun 2022
BTCRC-BRE18-337 (SABCS2023)	Phase 2	Triple Negative Breast Cancer germline BRCA 1/2 mutation	33	Gedatolisib	(pansrzgavi) = qvvyqomltz dlzecabjko (hmqqcmcwvi ) View more	-	15 Oct 2023
JPRN-UMIN000020585 (EAGLE-PAT/LC-SCRUM-Japan, ASCO2020)	Phase 2	Small Cell Lung Cancer	12	Gedatolisib	cxskfhqgml(xrdaisaepc) = Treatment-related G3 adverse events (hypertension, hypoalbuminemia, oral mucositis, ALT increased and creatinine increased) were observed in 4 pts mkgptutfno (bbyxnuablj )	Negative	25 May 2020
NCT02069158 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Solid tumor First line	17	Paclitaxel+Carboplatin+Gedatolisib	(iahmdpvyif) = neutropenia (35%), anemia (18%), and mucositis (12%) ldrccdqnxj (yfjjnapzva ) View more	Positive	15 Sep 2021
NCT02069158 (ESMO2020)	Phase 1	Advanced Malignant Solid Neoplasm	17	Gedatolisib	(khfqtnooki) = neutropenia (6 pts), anemia (3 pts), mucositis (2 pts) and fatigue, nausea, peripheral neuropathy, thrombocytopenia, hypokalemia, hypomagnesemia, infective colitis and aortic intramural hematoma (one pt each) yokyxckotz (vhjsjznonr )	-	17 Sep 2020

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