A Study of RO5212054 (PLX3603) in Participants With BRAF... | NCT01143753

NCT01143753

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2010-018330-42	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RO5212054: Continuous Dosing Cohort	Experimental	Participants will receive RO5212054 in escalating dose levels.	Drug: RO5212054
RO5212054: New Formulation (F05) Bridging Cohort	Experimental	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.	Drug: RO5212054

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RO5212054	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Dose Limiting Toxicity		Baseline up to 21 days
Maximal Tolerated Dose of RO5212054		Baseline up to 21 days
Maximum Plasma Concentration of RO5212054	Detailed timeframe: Pre-dose (0 hour [hr]): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)	Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
Time to Reach Maximum Plasma Concentration of RO5212054	Detailed timeframe: Pre-dose (0 hr): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)	Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
Area Under The Plasma Concentration-Time Curve of RO5212054	Detailed timeframe: Pre-dose (0 hr): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)	Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)

Measure	Description	Time Frame
Percentage of Participants With Adverse Events		Baseline up to approximately 7 years

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Royal Adelaide Hospital; Oncology		Adelaide	South Australia	5000	Australia
Austin Hospital; Medical Oncology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26310975	Derived	Dienstmann R, Lassen U, Cebon J, Desai J, Brown MP, Evers S, Su F, Zhang W, Boisserie F, Lestini B, Schostack K, Meresse V, Tabernero J. First-in-Man Dose-Escalation Study of the Selective BRAF Inhibitor RG7256 in Patients with BRAF V600-Mutated Advanced Solid Tumors. Target Oncol. 2016 Apr;11(2):149-56. doi: 10.1007/s11523-015-0381-x.