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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01107418




Registration number
NCT01107418
Ethics application status
Date submitted
12/04/2010
Date registered
21/04/2010
Date last updated
26/08/2015

Titles & IDs
Public title
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
Scientific title
A Phase I, Randomized, Open-label, Multi-center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients
Secondary ID [1] 0 0
NP25163
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 - RO5185426
Treatment: Drugs - RO5185426
Treatment: Drugs - RO5185426
Treatment: Drugs - RO5185426
Treatment: Drugs - RO5185426

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -


Treatment: Drugs: RO5185426
dosage b) orally twice daily, days 1-15 (morning dose)

Treatment: Drugs: RO5185426
dosage c) orally twice daily, days 1-15 (morning dose)

Treatment: Drugs: RO5185426
dosage d) orally twice daily, days 1-15 (morning dose)

Treatment: Drugs: RO5185426
960 mg orally twice daily, from day 22 onward

Treatment: Drugs: RO5185426
dosage a) orally twice daily, days 1-15 (morning dose)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 1
Timepoint [1] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1
Primary outcome [2] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 1
Timepoint [2] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 1
Primary outcome [3] 0 0
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 1
Timepoint [3] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1
Primary outcome [4] 0 0
Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 1
Timepoint [4] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1
Primary outcome [5] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 9
Timepoint [5] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9
Primary outcome [6] 0 0
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 9
Timepoint [6] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9
Primary outcome [7] 0 0
Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 9
Timepoint [7] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9
Primary outcome [8] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 15
Timepoint [8] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 15
Primary outcome [9] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 15
Timepoint [9] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 15
Primary outcome [10] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC[0-168h]) of Vemurafenib on Day 15
Timepoint [10] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15
Primary outcome [11] 0 0
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15
Timepoint [11] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15
Primary outcome [12] 0 0
Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 15
Timepoint [12] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15
Primary outcome [13] 0 0
Apparent Clearance (CL/F) of Vemurafenib on Day 15
Timepoint [13] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15
Primary outcome [14] 0 0
Terminal Elimination Half-Life (t1/2) of Vemurafenib on Day 15
Timepoint [14] 0 0
Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15
Primary outcome [15] 0 0
Accumulation Ratio of Vemurafenib on Day 15
Timepoint [15] 0 0
Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1 and 15
Secondary outcome [1] 0 0
Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
Timepoint [1] 0 0
Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)

Eligibility
Key inclusion criteria
* adult patients, >/=18 years of age
* histologically confirmed metastatic melanoma, stage IIIc or IV (AJCC)
* failure of at least one prior standard of care regimen
* positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)
* ECOG performance status 0 or 1
* adequate hematologic, renal and liver function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* active CNS lesions on CT/MRI within 28 days prior to enrollment
* history of spinal cord compression o carcinomatous meningitis
* anticipated or ongoing anti-cancer therapies other than those administered in this study
* previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
* severe cardiovascular disease within 6 months prior to study
* previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 1
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
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3181 - 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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia

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/NCT01107418