Overview

This trial is active, not recruiting.

Condition malignant melanoma
Treatment vemurafenib
Phase phase 2
Target BRAF
Sponsor Hoffmann-La Roche
Start date October 2009
End date September 2010
Trial size 132 participants
Trial identifier NCT00949702, NP22657

Summary

This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is <100 patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vemurafenib
960 mg b.i.d. continuous oral dosing

Primary Outcomes

Measure
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
time frame: From first treatment through September 27, 2010

Secondary Outcomes

Measure
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
time frame: From first treatment through September 27, 2010
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
time frame: From first treatment through September 27, 2010
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
time frame: From first treatment through September 27, 2010
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
time frame: From first treatment through September 27, 2010
Overall Survival
time frame: From first treatment through September 27, 2010
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
time frame: From first treatment through September 27, 2010
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
time frame: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
time frame: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Vemurafenib Plasma Levels at Various Treatment Cycles
time frame: Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
time frame: Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Percentage of Patients With Adverse Event
time frame: From first treatment through September 27, 2010

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - adult patients >/=18 years of age - histologically confirmed metastatic melanoma (Stage IV, AJCC) - patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.) - BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay) - measurable disease by RECIST criteria - negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion Exclusion Criteria: - active CNS metastases on CT/MRI within 28 days prior to enrollment - history of or known carcinomatous meningitis - previous treatment with BRAF (sorafenib allowed) or MEK inhibitor - cardiac dysrhythmias >2 NCI CTCAE or treatment with drugs with dysrhythmic potential - uncontrolled hypertension(>150/100mmHg) despite optimal medical therapy - infectious disease including HIV, HBV and HCV

Additional Information

Official title An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.