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A Dose-Escalating Study of RO4987655 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: NCT00817518
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily 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 metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: RO4987655 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
Study Start Date : January 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: 1 Drug: RO4987655
Administered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2)

Experimental: 2 Drug: RO4987655
Administered po daily for 28 days, at escalating doses , with a starting dose of 1mg (Part 1). Optimal biological dose administered po daily until disease progression (Part 2)

Primary Outcome Measures :
  1. Maximum tolerated dose (Part 1) [ Time Frame: Reviewed after each 4 week cycle ]
  2. Tumor assessments (Part 2) [ Time Frame: Every 8 weeks ]

Secondary Outcome Measures :
  1. Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2) [ Time Frame: Reviewed after each 4 week cycle ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 or other responsive tumor type (Part 2);
  • measurable and/or evaluable disease (Part 1); >=1 measurable lesion (Part 2);
  • ECOG performance status 0-2.

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;
  • active CNS lesions;
  • acute or chronic infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817518

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Marseille, France, 13385
Paris, France, 75231
Paris, France, 75651
Villejuif, France, 94805
Essen, Germany, 45122
Amsterdam, Netherlands, 1066 CX
Barcelona, Spain, 08003
Madrid, Spain, 28050
Sevilla, Spain, 41013
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
London, United Kingdom, SW3 6JJ
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00817518    
Other Study ID Numbers: BO21189
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015