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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01143753




Registration number
NCT01143753
Ethics application status
Date submitted
11/06/2010
Date registered
14/06/2010
Date last updated
28/07/2017

Titles & IDs
Public title
A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors
Scientific title
An Open-Label, Multiple Ascending Dose (MAD) Study of the Selective BRAF Inhibitor RO5212054 (PLX3603) to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With BRAF V600-Mutated Advanced Solid Tumours
Secondary ID [1] 0 0
2010-018330-42
Secondary ID [2] 0 0
NP25247
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO5212054

Experimental: RO5212054: Continuous Dosing Cohort - Participants will receive RO5212054 in escalating dose levels.

Experimental: RO5212054: New Formulation (F05) Bridging Cohort - Participants will receive RO5212054 as a single dose of new formulation (F05-150 mg film-coated tablet with different ratios of ingredients than F03 to increase bioavailability) and a single dose of current clinical Formulation (F03-150 mg film-coated tablet) in a cross-over manner. Participants will be alternately assigned to receive either F05 or F03 as their first dose, followed by the opposite Formulation as their second dose. Dose of RO5212054 will be decided based on the results of continuous dosing cohort.


Treatment: Drugs: RO5212054
Participants will receive RO5212054 at a starting dose of 200 milligrams (mg) orally once daily in each 21 day cycle. Dose levels for escalation will be decided based on the safety assessment of previous cohort. Dose escalations in increments of 50-100 percent are planned.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Dose Limiting Toxicity
Timepoint [1] 0 0
Baseline up to 21 days
Primary outcome [2] 0 0
Maximal Tolerated Dose of RO5212054
Timepoint [2] 0 0
Baseline up to 21 days
Primary outcome [3] 0 0
Maximum Plasma Concentration of RO5212054
Timepoint [3] 0 0
Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
Primary outcome [4] 0 0
Time to Reach Maximum Plasma Concentration of RO5212054
Timepoint [4] 0 0
Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
Primary outcome [5] 0 0
Area Under The Plasma Concentration-Time Curve of RO5212054
Timepoint [5] 0 0
Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events
Timepoint [1] 0 0
Baseline up to approximately 7 years

Eligibility
Key inclusion criteria
- Advanced solid tumor

- Dose-escalation phase: Histologically confirmed, newly diagnosed or relapsed/
refractory unresectable American Joint Committee on Cancer (AJCC) Stage IIIC or IV
disease

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Adequate liver, renal and bone marrow function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants for whom standard therapy exists and is considered appropriate by the
investigator

- Prior treatment with an inhibitor of BRAF (sorafenib allowed)

- Active Central nervous system (CNS) lesions, or history of or known carcinomatous
meningitis

- Treatment with any chemotherapy, radiotherapy, immunotherapy or investigational agent
within 28 days prior to first dose of study drug

- Anticipated or ongoing anti-cancer therapies other than those administered in this
study

- Serious cardiovascular illness within the 6 months prior to study drug administration

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
27/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/05/2017
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital; Oncology - Adelaide
Recruitment hospital [2] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [3] 0 0
Royal Melbourne Hospital; Hematology and Medical Oncology - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
København Ø
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, multi-center study will evaluate the safety, tolerability, and
pharmacokinetics of RO5212054 [PLX3603] in participants with BRAF V600-mutated advanced solid
tumors. Cohorts of participants will receive escalating oral doses of RO5212054. Anticipated
time on study treatment is until disease progression or unacceptable toxicity occurs.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01143753
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01143753