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


N/A
N/A
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.


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

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Gary Palmer, MD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7272-A001-401

NCT ID:

NCT01432483

Start Date:

Completion Date:

Related Keywords:

  • Cancer
  • Cancer
  • ONTAK
  • Denileukin diftitox
  • persistent or recurrent disease
  • requiring continued delivery of essential cancer therapy

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