Overview

This trial is active, not recruiting.

Conditions thymoma, thymus cancer, thymic carcinoma
Treatment amrubicin
Phase phase 2
Sponsor Heather Wakelee
Collaborator Celgene
Start date June 2011
End date July 2014
Trial size 33 participants
Trial identifier NCT01364727, SU-01142011-7369, THOR0003

Summary

A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for thymic cancers.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Amrubicin 35mg/m2 IV days 1-3 every 3 weeks
amrubicin Calsed
35 mg/m2; IV on days 1-3 each 3 week cycle

Primary Outcomes

Measure
Overall response rate (ORR) = (CR+PR) in patients with thymic malignancies. ORR assessed radiographically by RECIST criteria.
time frame: 2 years

Secondary Outcomes

Measure
progression-free survival in patients with thymic malignancies treated with amrubicin
time frame: 2 years
disease control rate (DCR = CR+PR+SD) in patients with thymic malignancies treated with amrubicin.
time frame: 2 years

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
      Principal investigator Heather A. Wakelee
      Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
      Information provided to ClinicalTrials.gov by Stanford University.