Trials / Completed
CompletedNCT00692354
Safety Study to Evaluate CHR-2797 in Patients With Advanced Tumours
A Phase I Study to Evaluate the Safety and Tolerability, of the Aminopeptidase Inhibitor, CHR-2797, in Patients With Advanced Tumours
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Chroma Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study was to determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered orally, once daily, to patients with advanced solid tumours. The secondary objectives of this study were: * To determine pharmacokinetic parameters for CHR-2797 when administered orally at increasing dose levels; * To investigate the pharmacodynamic effects of CHR-2797 in blood mononuclear cells and, when possible, tumour cells; - To enable a preliminary assessment of anti-tumour activity of CHR-2797.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHR-2797 (tosedostat) | Drug was given orally, once daily, ensuring a dosing interval of approximately 24 hours. Dose escalations took place starting at 10mg and escalating (per protocol) as follows: 20, 40, 90, 130, 180, 240 and 320 mg |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2007-11-01
- Completion
- 2008-03-01
- First posted
- 2008-06-06
- Last updated
- 2010-08-06
Source: ClinicalTrials.gov record NCT00692354. Inclusion in this directory is not an endorsement.