A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

Start Date04 Aug 2021

Sponsor / Collaborator

Pierre Fabre Medicament Information

NCT03118817 / CompletedPhase 1

A Single-arm, Open-label, Multi-center, Phase I Expansion Study Evaluating the Efficacy and Safety of HM95573 Monotherapy in Patients With BRAF, KRAS or NRAS Mutation-positive Solid Cancers

This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene.

Start Date19 May 2017

Sponsor / Collaborator

Hanmi Pharmaceutical Co., Ltd.

NCT01928940 / CompletedPhase 2

A Japanese Open-label Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of GSK2118436 and GSK1120212 Combination Therapy in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) and BRAF V600E/K Mutation Positive Cutaneous Melanoma (Phase II Part).

This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).

Start Date15 Aug 2013

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with BRAF V600K Mutation-Positive Solid Tumors

100 Translational Medicine associated with BRAF V600K Mutation-Positive Solid Tumors

0 Patents (Medical) associated with BRAF V600K Mutation-Positive Solid Tumors

Literatures (Medical) associated with BRAF V600K Mutation-Positive Solid Tumors

01 May 2020·Cancer DiscoveryQ1 · MEDICINE

Pan-Cancer Efficacy of Vemurafenib in BRAFV600-Mutant Non-Melanoma Cancers

Q1 · MEDICINE

Article

Author: Riely, Gregory J. ; Puzanov, Igor ; Raje, Noopur S. ; Hyman, David M. ; Meric-Bernstam, Funda ; Lockhart, A. Craig ; Subbiah, Vivek ; Diamond, Eli L. ; Baselga, José ; Pitcher, Bethany ; Blay, Jean-Yves ; Roszik, Jason ; Riehl, Todd ; Sherman, Eric J. ; Wolf, Juergen ; Chau, Ian

AbstractBRAF V600 mutations occur in a wide range of tumor types, and RAF inhibition has become standard in several of these cancers. Despite this progress, BRAFV600 mutations have historically been considered a clear demonstration of tumor lineage context–dependent oncogene addiction, based predominantly on the insensitivity to RAF inhibition in colorectal cancer. However, the true broader activity of RAF inhibition pan-cancer remains incompletely understood. To address this, we conducted a multicohort “basket” study of the BRAF inhibitor vemurafenib in non-melanoma BRAFV600 mutation–positive solid tumors. In total, 172 patients with 26 unique cancer types were treated, achieving an overall response rate of 33% and median duration of response of 13 months. Responses were observed in 13 unique cancer types, including historically treatment-refractory tumor types such as cholangiocarcinoma, sarcoma, glioma, neuroendocrine carcinoma, and salivary gland carcinomas. Collectively, these data demonstrate that single-agent BRAF inhibition has broader clinical activity than previously recognized.Significance:These data suggest that BRAFV600 mutations lead to oncogene addiction and are clinically actionable in a broad range of non-melanoma cancers, including tumor types in which RAF inhibition is not currently considered standard of care.See related commentary by Ribas and Lo, p. 640.This article is highlighted in the In This Issue feature, p. 627

01 Apr 2018·Investigational New Drugs

Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF V600 mutation-positive solid tumors: a phase 1 study

Article

Author: Yamazaki, Naoya ; Fujiwara, Yutaka ; Tsutsumida, Arata ; Mukaiyama, Akihira ; Yamamoto, Noboru ; Tamura, Tomohide ; Nokihara, Hiroshi ; Yoshikawa, Shusuke ; Namikawa, Kenjiro ; Kiyohara, Yoshio ; Zhang, Fanghong

Background Dabrafenib is a BRAF inhibitor that has demonstrated clinical activity with a good tolerability profile in patients with BRAF ^V600E mutated metastatic melanoma. This study evaluated the safety and tolerability, pharmacokinetics and preliminary efficacy of dabrafenib in Japanese patients. Methods This phase I, open-label, dose escalation study was conducted in 12 Japanese patients with BRAF ^V600 mutation positive solid tumours. Primary endpoint was safety, assessed by monitoring and recording of all adverse events (AEs), serious AEs, drug-related AEs; secondary endpoints were pharmacokinetic profiles and efficacy measured by tumour response. This study is registered with ClinicalTrials.gov, number NCT01582997. Results Of the 12 patients enrolled, 3 each received 75 mg and 100 mg dabrafenib while 6 received 150 mg dabrafenib twice daily orally. Melanoma and thyroid cancer were the primary tumours reported in 11 (92%) and 1 (8%) patients respectively. Most AEs were grade 1 or 2 and considered related to study treatment. Most common AEs reported in the 12 patients were alopecia in 7 (58%); pyrexia, arthralgia and leukopenia in 6 (50%) each, hyperkeratosis and nausea in 4 (33%) each. Partial response as best overall response was reported in 7 of 12 (58%) patients and in 6 (55%) with malignant melanoma. No dose-limiting toxicity (DLTs) were reported during the DLT evaluation periods. Conclusions Dabrafenib was well tolerated and rapidly absorbed administered as single- or multiple dose. Comparable safety and pharmacokinetic profiles were observed compared with non-Japanese patients. Dabrafenib has promising clinical activity in Japanese patients with BRAF mutated malignant melanoma.

01 Jan 2017·Clinical Chemistry and Laboratory Medicine (CCLM)Q3 · MEDICINE

Detection of BRAFV600K mutant tumor-derived DNA in the pleural effusion from a patient with metastatic melanoma

Q3 · MEDICINE

Article

Author: Sakaizawa, Kaori ; Okuyama, Ryuhei ; Ashida, Atsuko ; Uhara, Hisashi

The author presented a case of 74-yr-old Japanese patient with metastatic melanoma harboring a BRAF^v600k mutation detected in circulating cell-free DNA isolated from a pleural effusion.The author analyzed circulating cell-free DNA from peripheral blood, pleural effusion and intransit metastasis for the BRAF mutation using droplet digital PCR.BRAF^v600k circulating cell-free DNA was detected in total cfDNA derived from the pleural effusion at the time of thoracentesis, although it was not detected in peripheral blood on Days-5, 3, 10, 16 and 23.Metastatic melanoma patient received nivolumab (2mg/kg) every 3 wk, a pleural effusion developed 3 mo after commencing treatment; both the size and the number of lung metastases increased concomitantly.The patient was switched from nivolumab to vemurafenib (1920 mg daily).Adverse events, including a rash and joint pain, led to transient discontinuation of vemurafenib.The author concluded that clearance of circulating cell-free DNA was related to early detection of BRAF^v600k tumor-derived DNA cell-free DNA in pleural effusion of 74-yr-old Japanese patient with metastatic melanoma.

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