EUCTR2011-004426-10-DEActive, not recruitingPhase 1
An open-label, phase II study of vemurafenib in patients with BRAF V600 mutation-positive cancers
F. Hoffman-La Roche Ltd.0 sites500 target enrollmentStarted: February 22, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •For solid tumor cancer patients only:
- •Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) that harbor a BRAF V600 mutation and are refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator
- •Measurable disease according to RECIST, v1.1
- •For multiple myeloma (MM) patients only:
- •Patients with a confirmed diagnosis of MM and harbor a BRAF V600 mutation
- •Patients must have received at least one line of prior systemic therapy for the treatment of MM. A line of treatment is sequential treatment without interruption for response and subsequent progression
- •Patients treated with local radiotherapy (with or without concomitant exposure to steroids for pain control or management of cord/nerve root compression), two weeks must have lapsed since the last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry into the Study deferred until the radiotherapy is completed and two weeks have passed since the last date of therapy
- •Patients must have relapsed and/or refractory MM with measurable disease, defined as disease that can be measured either by serum or urinary evaluation of the monoclonal component or by serum assay of free light chain (FLC) based on at least one of the following three measurements:
- •oSerum M-protein > 0.5 g/dL
- •oUrine M-protein > 200 mg per 24 hours
- •oInvolved FLC level > 10 mg/dL (> 100 mg/L) provided serum FLC ratio is abnormal
- •For all patients (solid tumors and MM patients):
- •Male or female = 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2
- •Adequate hematologic, renal, and liver function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
Exclusion Criteria
- •Melanoma, papillary thyroid cancer, or hematological malignancies (with the exception of multiple myeloma) •Uncontrolled concurrent malignancy (early stage or chronic disease is allowed if not requiring active therapy or intervention and is under control)
- •For MM, solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- •Active or untreated CNS metastases. Patients with brain metastasis are eligible if asymptomatic, off corticosteroid therapy and without evidence of disease progression in brain for = 2 months. Patients with incidentally found brain metastases that are asymptomatic and for which no treatment is planned are also eligible.
- •Concurrent administration of any anti-cancer therapies (e.g., chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
- •Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)
- •Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
Investigators
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