|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00817518 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: RO4987655 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | February 2013 |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Please reference Study ID Number: BO21189 | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
| France | |
| Active, not recruiting | |
| Marseille, France, 13385 | |
| Active, not recruiting | |
| Paris, France, 75231 | |
| Recruiting | |
| Paris, France, 75651 | |
| Active, not recruiting | |
| Villejuif, France, 94805 | |
| Germany | |
| Completed | |
| Essen, Germany, 45147 | |
| Netherlands | |
| Active, not recruiting | |
| Amsterdam, Netherlands, 1066 CX | |
| Spain | |
| Active, not recruiting | |
| Barcelona, Spain, 08003 | |
| Active, not recruiting | |
| Madrid, Spain, 28050 | |
| Recruiting | |
| Sevilla, Spain, 41013 | |
| United Kingdom | |
| Recruiting | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Recruiting | |
| London, United Kingdom, SW3 6JJ | |
| Active, not recruiting | |
| Oxford, United Kingdom, OX3 7LJ | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00817518 History of Changes |
| Other Study ID Numbers: | BO21189, 2007-002021-77 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 17, 2012 |
| Health Authority: | Netherlands: Medicines Evaluation Board |
|
Neoplasms |