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A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

NCT00878800 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-07-28

Study results available
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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

  • Dose Escalation: Solid Tumors
  • MTD: Soft Tissue Sarcomas

Interventions

DRUG

PXD101

Administered in combination with doxorubicin (BelDox)

DRUG

Doxorubicin

Administered in combination with PXD101 (BelDox)

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Denmark
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878800 on ClinicalTrials.gov