CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
PXD101 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00878800
NCT00878800Phase 2Completed
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A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

Valerio Therapeutics·interventional·Posted Apr 9, 2009·Updated Jul 28, 2015

In Brief

A Phase 2 clinical trial evaluating PXD101 and Doxorubicin for Dose Escalation: Solid Tumors and MTD: Soft Tissue Sarcomas. Completed, enrolled 41 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDose Escalation: Solid Tumors, MTD: Soft Tissue Sarcomas
CountriesDenmark, United Kingdom
CollaboratorsSpectrum Pharmaceuticals, Inc

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2009
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.2 years ago

Interventions

PXD101drug

Administered in combination with doxorubicin (BelDox)

Doxorubicindrug

Administered in combination with PXD101 (BelDox)