Trial Information
Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
AEs, laboratory parameters.
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO21321
NCT ID:
NCT00532090
Start Date:
November 2007
Completion Date:
February 2011
Related Keywords:
Name | Location |
|
Austin, Texas 78705 |
|
Hackensack, New Jersey 07601 |
|
Denver, Colorado |
|
Boston, Massachusetts |