Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 15, 2008
Last updated: November 3, 2014
Last verified: November 2014

October 15, 2008
November 3, 2014
November 2008
September 2011   (final data collection date for primary outcome measure)
  • Maximum tolerated dose (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Tumor assessments (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773526 on Archive Site
AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
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

This study will determine the maximum tolerated dose and the dose limiting toxic ities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patie nts with metastatic or advanced solid tumors. In the first part of the study, gr oups of patients will by sequentially enrolled to receive ascending oral doses o f RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in s ubsequent groups of patients after a successful assessment of the safety and tol erability of the previous dose. In Part 2 of the study, patients with selected t umor types will be randomized to receive either the optimal biological dose or t he maximum tolerated dose of RO5126766 daily. The anticipated time on study trea tment is until disease progression, and the target sample size is 100 individual s.

Not Provided
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: RO5126766
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).
Experimental: 1
Intervention: Drug: RO5126766
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
France,   Spain,   United Kingdom
NO21895, 2008-002298-11
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP