A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors

Hoffmann-La Roche45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

RO5212054DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (5)

Royal Adelaide Hospital; Oncology

Adelaide, South Australia, Australia

Austin Hospital; Medical Oncology

Heidelberg, Victoria, Australia

Royal Melbourne Hospital; Hematology and Medical Oncology

Parkville, Victoria, Australia

Rigshospitalet, Onkologisk Klinik

København Ø, Denmark

Outcomes

Primary Outcomes

Percentage of Participants With Dose Limiting Toxicity

Time frame: Baseline up to 21 days

Maximal Tolerated Dose of RO5212054

Time frame: 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)

Time frame: 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)

Time frame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)

Area Under The Plasma Concentration-Time Curve of RO5212054

Time frame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)

Secondary Outcomes

Percentage of Participants With Adverse Events

Time frame: Baseline up to approximately 7 years

Data from ClinicalTrials.gov

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