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

NCT00817518 | Completed Phase 1

• 2 other identifiers: BO211892007-002021-77
• Study Type: interventional
• Target: 145
• Locations: 5 countries
• Sites: 12

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (Part 1)

  Reviewed after each 4 week cycle

• Tumor assessments (Part 2)

  Every 8 weeks

Secondary Outcomes (1)

• Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)

  Reviewed after each 4 week cycle

Study Arms (2)

1

EXPERIMENTAL

Drug: RO4987655

2

EXPERIMENTAL

Drug: RO4987655

Interventions

RO4987655 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)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Paris, 75231, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Amsterdam, 1066 CX, Netherlands

Location

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

Unknown Facility

Madrid, Madrid, 28050, Spain

Location

Unknown Facility

Seville, Sevilla, 41013, Spain

Location

Unknown Facility

Cambridge, CB2 2QQ, United Kingdom

Location

Unknown Facility

London, SW3 6JJ, United Kingdom

Location

Unknown Facility

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

CH 4987655

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

GB (3); DE (1); ES (3); FR (4); NL (1)