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

Eisai

Status

Conditions: Cancer

Treatments: Drug: Denileukin diftitox (ONTAK)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01432483

E7272-A001-401

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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