NCT01164033
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- RO5045337
- Conditions
- Neoplasms
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 76
- Primary Endpoint
- Examination of potential food-effect on pharmacokinetics of RO5045337
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Intervention: RO5045337
B
Intervention: RO5045337
C
Intervention: RO5045337
D
Intervention: RO5045337
Outcomes
Primary Outcomes
Examination of potential food-effect on pharmacokinetics of RO5045337
Time Frame: 3 weeks
Evaluation of relative bioavailability of RO5045337
Time Frame: 3 weeks
Secondary Outcomes
- Evaluation of safety and tolerability of RO5045337(3 weeks)
- Evaluation of pharmacodynamics and biomarkers(3 weeks)
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