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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00817518
First received: December 16, 2008
Last updated: September 1, 2015
Last verified: September 2015

December 16, 2008
September 1, 2015
January 2009
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00817518 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • 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)
  • 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)
  • Experimental: 1
    Intervention: Drug: RO4987655
  • Experimental: 2
    Intervention: Drug: RO4987655
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands,   Spain,   United Kingdom
 
NCT00817518
BO21189, 2007-002021-77
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP