A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors

NCT ID: NCT00817518

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

RO4987655

Intervention Type: DRUG

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)

2

Group Type: EXPERIMENTAL

RO4987655

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Marseille, , France

Paris, , France

Paris, , France

Villejuif, , France

Essen, , Germany

Amsterdam, , Netherlands

Barcelona, Barcelona, Spain

Madrid, Madrid, Spain

Seville, Sevilla, Spain

Cambridge, , United Kingdom

London, , United Kingdom

Oxford, , United Kingdom

Countries

France; Germany; Netherlands; Spain; United Kingdom

Other Identifiers

2007-002021-77

Identifier Type: -

Identifier Source: secondary_id

BO21189

Identifier Type: -

Identifier Source: org_study_id