A Study of R547 in Patients With Advanced Solid Tumors.

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: RG547

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400296

NP18378

Details and patient eligibility

About

This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• locally advanced or metastatic solid tumors;
• measurable or evaluable disease.

Exclusion criteria

• prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
• prior history of CNS metastases with disease progression;
• patients taking strong inhibitors and/or inducers of CYP3A4.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RG547