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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00817518
First received: December 16, 2008
Last updated: February 17, 2014
Last verified: February 2014
  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: February 2014
Estimated Primary Completion Date: February 2014 (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
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, see Learn About Clinical Studies.

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, 45122
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: February 17, 2014
Health Authority: Netherlands: Medicines Evaluation Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 15, 2014