A Study of RO5045337 in Patients With Solid Tumors

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: RO5045337

Study type: Interventional

Funder types: Industry

Identifiers

NCT01164033

NP25299

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

A

Active Comparator group

Treatment:

Drug: RO5045337

B

Experimental group

Treatment:

Drug: RO5045337

C

Experimental group

Treatment:

Drug: RO5045337

D

Experimental group

Treatment:

Drug: RO5045337