Trial Information

Summary: A Study of 3 Weekly Tubulin Polymerisation Inhibitor (Tub-2) in Patients With Advanced Solid Tumors.

Status: Completed

Protocol Number: BO17688

Sponsor: Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: An open-label, dose-escalation study to determine the recommended dose of Tubulin Polymerisation Inhibitor (Tub-2), administered every 3 weeks, in patients with advanced solid tumors

Brief Summary: This study will evaluate the maximum tolerated dose, dose-limiting toxicity and safety/tolerability profile of Tub-2 in patients with advanced solid tumors. In a drug-drug interaction substudy, the effect of Tub-2 on CYP3A4 activity will be measured. Groups of patients will receive ascending doses of Tub-2 as intravenous infusions every 3 weeks, administered over 90 minutes.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. When the recommended dose has been identified additional patients may be enrolled to provide better characterization of that dose level. A separate cohort of patients will also be enrolled into the drug-drug interaction substudy. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 30.

Study Phase: I

Study Design / Study Details:

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

Study Type:

Condition: Neoplasms

Intervention Type: Drug

Intervention Name: Tubulin Polymerisation Inhibitor (Tub-2)

Primary Outcome: 1. Adverse events; laboratory parameters; dose-limiting toxicity.

Key Secondary Outcomes: 1. Efficacy: tumor assessments. Pharmacokinetics: plasma profile of Tub-2. Pharmacodynamics: microtubular changes in PBMC.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/16/2006

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:14:24 PM