A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00817518
First received: December 16, 2008
Last updated: May 7, 2013
Last verified: May 2013
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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 1 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Maximum tolerated dose (Part 1) [ Time Frame: Reviewed after each 4 week cycle ] [ Designated as safety issue: No ]
- Tumor assessments (Part 2) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2) [ Time Frame: Reviewed after each 4 week cycle ] [ Designated as safety issue: No ]
| Enrollment: | 145 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| 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 |
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817518
Locations
| France | |
| Marseille, France, 13385 | |
| Paris, France, 75231 | |
| Paris, France, 75651 | |
| Villejuif, France, 94805 | |
| Germany | |
| Essen, Germany, 45147 | |
| Netherlands | |
| Amsterdam, Netherlands, 1066 CX | |
| Spain | |
| 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
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | 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: | May 7, 2013 |
| Health Authority: | Netherlands: Medicines Evaluation Board |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013