A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: RG1530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493155

NO18674

Details and patient eligibility

About

This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• cancer not amenable to curative treatment (ie advanced and/or metastatic);
• measurable or evaluable disease;
• adequate cardiac, hepatic and renal function.

Exclusion criteria

• patients with known CNS metastases;
• serious cardiovascular illness or other medical conditions;
• prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment;
• inability to swallow oral medications, or impaired gastrointestinal absorption.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RG1530