Trial Information

Summary: A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

Status: Recruiting

Protocol Number: NO21321

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients with Refractory Metastatic or Locally Advanced Solid Tumors

Brief Summary: This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733, administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess two different dosing schedules; in one schedule R4733 will be administered on days 1, 2, 3, 8, 9, and 10 of each 21 day cycle, and in the other on days 1-7 of each 21 day cycle. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals. Target sample size is 96.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Neoplasms

Intervention Type: Drug

Intervention Name: R4733

Primary Outcome: 1. AEs, laboratory parameters. Time frame: Throughout study

Key Secondary Outcomes: 1. Tumor assessments Time frame: Every 6 weeks 2. Pharmacokinetic profile Time frame: After first dose, last dose of cycle 1, and first dose of cycle 2.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2007

Trial Registration Date: 09/17/2007

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:33:50 PM