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

Sponsor

Eisai Inc. (Industry)

Overall Status

No longer available

CT.gov ID

NCT01432483

Collaborator

(none)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Denileukin diftitox (ONTAK)

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 Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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