A Study of RO5045337 in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: RO5045337

• Registration Number: NCT01164033
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Start: 2010-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	RO5045337	-
D	RO5045337	-
B	RO5045337	-
C	RO5045337	-

Primary Outcome Measures

Name	Time	Method
Examination of potential food-effect on pharmacokinetics of RO5045337	3 weeks
Evaluation of relative bioavailability of RO5045337	3 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability of RO5045337	3 weeks
Evaluation of pharmacodynamics and biomarkers	3 weeks