A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773526

Enrollment

Registered

2008-10-16

Start date

2008-11-30

Completion date

2011-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

Interventions

DRUGRO5126766

Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (Part 1)	Throughout study
Tumor assessments (Part 2)	Event driven

Secondary

Measure	Time frame
AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).	Throughout study

Countries

France, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026