Trials / Completed
CompletedNCT00878800
A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Valerio Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin administered q 3 weeks in patients with advanced solid tumours. Once the Maximum Tolerable Dose has been established, up to a total of 20-40 patients with Soft Tissue Sarcoma may be enrolled at the MTD dose level to examine efficacy and safety in this specific patient population. The trial is stopped if no more than 2 responses are seen among the first 20 of these patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PXD101 | Administered in combination with doxorubicin (BelDox) |
| DRUG | Doxorubicin | Administered in combination with PXD101 (BelDox) |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2012-10-01
- Completion
- 2012-10-01
- First posted
- 2009-04-09
- Last updated
- 2015-07-28
- Results posted
- 2014-12-29
Locations
3 sites across 2 countries: Denmark, United Kingdom
Source: ClinicalTrials.gov record NCT00878800. Inclusion in this directory is not an endorsement.