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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773526
First received: October 15, 2008
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: RO5126766
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773526

Locations
France
Villejuif, France, 94805
Spain
Barcelona, Spain, 08003
United Kingdom
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773526     History of Changes
Other Study ID Numbers: NO21895, 2008-002298-11
Study First Received: October 15, 2008
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014