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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773526
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

October 15, 2008
October 16, 2008
November 2, 2016
November 2008
September 2011   (Final data collection date for primary outcome measure)
  • Maximum tolerated dose (Part 1) [ Time Frame: Throughout study ]
  • Tumor assessments (Part 2) [ Time Frame: Event driven ]
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 ]
Same as current
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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 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.
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Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
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*   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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   Spain,   United Kingdom
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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