Clinical trial · Interventional
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
NCT01524978CI-TRIAL-00030428completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma, Neoplasms | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - vemurafenib
- description
- Participants with NSCLC will be treated with vemurafenib monotherapy.
- interventionNames
- Drug: vemurafenib
- type
- EXPERIMENTAL
- label
- Cohort 2: Ovarian Cancer - vemurafenib
- description
- Participants with ovarian cancer will be treated with vemurafenib monotherapy.
- interventionNames
- Drug: vemurafenib
- type
- EXPERIMENTAL
- label
- Cohort 3a: Colorectal Cancer - vemurafenib
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Must have recovered from all side effects of their most recent systemic or local treatment * Adequate hematological, renal and liver function For solid tumors only: * Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist * Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) For multiple myeloma only: * Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation * Must have received at least one prior systemic therapy for the treatment of multiple myeloma * Treated with local radiotherapy * Must have relapsed and/or refractory multiple myeloma with measurable disease Exclusion Criteria: * Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma) * Uncontrolled concurrent malignancy * Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia * Active or untreated central nervous system (CNS) metastases * History of or known carcinomatous meningitis * Concurrent administration of any anti-cancer therapies other than those administered in this study * Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
References
Publications (3)
- DERIVEDSubbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7. PMID 37934000
- DERIVEDKaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23. PMID 30351999
- DERIVEDHyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309. PMID 26287849