Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

• Conditions: Cancer

• Registration Number: NCT01432483
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.

Detailed Description

The Access Program will be provided as long as appropriate according to the judgment of the provider. If Denileukin diftitox (ONTAK) becomes commercially available without restriction, then the access program will be discontinued.

Study Timeline

• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To receive denileukin diftitox (ONTAK) under this protocol, the patient's physician must request this therapy for the specific patient. Patients may continue treatment with denileukin diftitox if they:

• Are currently on therapy with denileukin diftitox and require ongoing therapy to maintain control of their disease.
• Are willing and able to comply with all aspects of the Access Protocol
• Provide written informed consent to participate

Exclusion Criteria

Patients are not eligible for the Access Program with denileukin diftitox if they:

• Are not currently on denileukin diftitox therapy

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified