Trial Information

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

Status: Completed

Protocol Number: BO17687

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 weekly, 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. Groups of patients will receive ascending doses of Tub-2 as weekly intravenous infusions, 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. 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:

Interventional

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:

  • adult patients, >= 18 years of age;
  • documented advanced stage primary or metastatic solid tumors, refractory to standard treatment or for which no standard treatment exists;
  • evidence of radiologically measurable or clinically evaluable disease;
  • last dose of systemic anti-neoplastic therapy >4 weeks.

Exclusion Criteria:

  • concomitant administration of any potent CYP 3A4 substrate, inducer or inhibitor;
  • clinically significant cardiovascular disease;
  • ocular disease predisposing to cataract formation, or pre-existing cataract;
  • cumulative total of >=1 year of glucocorticoid treatment over past 5 years.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/16/2006

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Barcelona, Spain, 08035
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 1:44:56 PM


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