An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 52
- Primary Endpoint
- Tumor assessments (Part 2)
Study Overview
Brief Summary
This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients, >=18 years of age;
- •advanced and/or metastatic cancer not amenable to standard therapy;
- •any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);
- •measurable and/or evaluable disease (Part 1), >=1 measurable lesion (Part 2);
- •ECOG performance status 0-1.
Exclusion Criteria
- •prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- •prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
- •known past or present CNS metastases;
- •acute or chronic infection.
Arms & Interventions
1
Intervention: RO5126766 (Drug)
Outcomes
Primary Outcomes
Tumor assessments (Part 2)
Time Frame: Event driven
Maximum tolerated dose (Part 1)
Time Frame: Throughout study
Secondary Outcomes
- AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).(Throughout study)