An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms
Both
Neoplasms
Trial Information
An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Histologically confirmed solid tumor
- Life expectancy of >/=12 weeks
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
- Patients receiving any other investigational agent or therapy administered with the
intention to treat their malignancy within 28 days prior to study start
- Patients with pre-existing gastro-intestinal disorder
- Patients with uncontrolled intercurrent illness
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Examination of potential food-effect on pharmacokinetics of RO5045337
Outcome Time Frame:
3 weeks
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:
NP25299
NCT ID:
NCT01164033
Start Date:
August 2010
Completion Date:
July 2013
Related Keywords:
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Phoenix, Arizona 85012 | |
| Austin, Texas 78705 | |
| Kansas City, Kansas 66160 | |
| Baltimore, Maryland 21287 |
