A Study of RO5045337 in Patients With Solid Tumors

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164033
• Other study ID #: NP25299
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2010
• Last updated: November 1, 2016
• Start date: August 2010
• Est. completion date: May 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RO5045337
single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of potential food-effect on pharmacokinetics of RO5045337		3 weeks	No
Primary	Evaluation of relative bioavailability of RO5045337		3 weeks	No
Secondary	Evaluation of safety and tolerability of RO5045337		3 weeks	No
Secondary	Evaluation of pharmacodynamics and biomarkers		3 weeks	No