A Study of RO5045337 in Patients With Solid Tumors

Hoffmann-La Roche76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

RO5045337DRUG

single oral dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Scottsdale, Arizona, United States

Unnamed facility

Kansas City, Kansas, United States

Unnamed facility

Kensignton, Maryland, United States

Unnamed facility

Dallas, Texas, United States

Unnamed facility

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

Time frame: 3 weeks

Evaluation of pharmacodynamics and biomarkers

Time frame: 3 weeks

Data from ClinicalTrials.gov

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