Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00949702




Registration number
NCT00949702
Ethics application status
Date submitted
28/07/2009
Date registered
30/07/2009
Date last updated
25/07/2017

Titles & IDs
Public title
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
Scientific 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
Secondary ID [1] 0 0
NP22657
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vemurafenib

Experimental: Single arm -


Treatment: Drugs: vemurafenib
960 mg b.i.d. continuous oral dosing
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Timepoint [1] 0 0
From first treatment through September 27, 2010
Secondary outcome [1] 0 0
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Timepoint [1] 0 0
From first treatment through September 27, 2010
Secondary outcome [2] 0 0
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Timepoint [2] 0 0
From first treatment through September 27, 2010
Secondary outcome [3] 0 0
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Timepoint [3] 0 0
From first treatment through September 27, 2010
Secondary outcome [4] 0 0
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Timepoint [4] 0 0
From first treatment through September 27, 2010
Secondary outcome [5] 0 0
Overall Survival
Timepoint [5] 0 0
From first treatment through September 27, 2010
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
From first treatment through September 27, 2010
Secondary outcome [7] 0 0
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
Timepoint [7] 0 0
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Secondary outcome [8] 0 0
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
Timepoint [8] 0 0
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
Secondary outcome [9] 0 0
Vemurafenib Plasma Levels at Various Treatment Cycles
Timepoint [9] 0 0
Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
Secondary outcome [10] 0 0
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Timepoint [10] 0 0
Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
Secondary outcome [11] 0 0
Percentage of Patients With Adverse Event
Timepoint [11] 0 0
From first treatment through September 27, 2010

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2014
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle; Melanoma Clinic - Newcastle
Recruitment hospital [2] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00949702