Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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 CYP3A4 substrate, inducer or inhibitor;
- clinically significant cardiovascular disease;
- ocular diseases predisposing to cataract formulation, 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 Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
