A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00532090
First received: September 18, 2007
Last updated: August 26, 2014
Last verified: August 2014

September 18, 2007
August 26, 2014
November 2007
August 2010   (final data collection date for primary outcome measure)
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters.
Complete list of historical versions of study NCT00532090 on ClinicalTrials.gov Archive Site
  • Tumor assessments [ Time Frame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile [ Time Frame: After first dose and last dose (or day 15) of cycles 1 and 2 ] [ Designated as safety issue: No ]
Efficacy: Tumor assessments every 6 weeks. Pharmacokinetic: Pharmacokinetic profile following first dose, last dose of cycle 1, and first dose of cycle 2.
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory m etastatic or locally advanced solid tumors. The study will assess three differen t dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule contin uously daily. The starting dose for each dosing regimen will be escalated in sub sequent groups of patients after a satisfactory assessment of the safety and tol erability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 10 0-200 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: RG4733
    Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule
    Other Name: RO4929097
  • Drug: RG4733
    Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
    Other Name: RO4929097
  • Drug: RG4733
    Administered orally daily at ascending doses to successive cohorts of patients
    Other Name: RO4929097
  • Experimental: 1
    Intervention: Drug: RG4733
  • Experimental: 2
    Intervention: Drug: RG4733
  • Experimental: 3
    Intervention: Drug: RG4733
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced and/or metastatic solid tumor malignancy;
  • measurable or evaluable disease;
  • ECOG performance status 0 or 1.

Exclusion Criteria:

  • prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
  • prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
  • major surgery within 28 days of first receipt of study drug.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00532090
NO21321
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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