A Study of RO5045337 in Patients With Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164033

Enrollment

Registered

2010-07-16

Start date

2010-08-31

Completion date

2013-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

Interventions

DRUGRO5045337

single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Examination of potential food-effect on pharmacokinetics of RO5045337	3 weeks
Evaluation of relative bioavailability of RO5045337	3 weeks

Secondary

Measure	Time frame
Evaluation of safety and tolerability of RO5045337	3 weeks
Evaluation of pharmacodynamics and biomarkers	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026