A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors
Inclusion Criteria:
- adult patients, >=18 years of age;
- locally advanced or metastatic solid tumors;
- measurable or evaluable disease.
Exclusion Criteria:
- prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
- prior history of CNS metastases with disease progression;
- patients taking strong inhibitors and/or inducers of CYP3A4.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group 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:
NP18378
NCT ID:
NCT00400296
Start Date:
May 2005
Completion Date:
November 2008
Related Keywords:
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Austin, Texas 78705 | |
| Hackensack, New Jersey 07601 | |
| Denver, Colorado | |
| Charlotte, North Carolina |
