A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
Inclusion Criteria:
- adult patients, >=18 years of age;
- solid tumor malignancies;
- failed prior therapies, or no standard therapy available;
- ECOG performance status of 0-2.
Exclusion Criteria:
- patients receiving any other agent or therapy to treat their malignancy;
- pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
- clinically significant cardiovascular disease.
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:
MTD and associated dose schedule
Outcome Time Frame:
Every 28 days
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:
NO21280
NCT ID:
NCT00559533
Start Date:
December 2007
Completion Date:
November 2012
Related Keywords:
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Albany, New York 12208 | |
| Austin, Texas 78705 | |
| Denver, Colorado | |
| Boston, Massachusetts |
