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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01432483
First received: September 7, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention
Cancer
Drug: Denileukin diftitox (ONTAK)

Study Type: Expanded Access     What is Expanded Access?
Official Title: Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Intervention Details:
    Drug: Denileukin diftitox (ONTAK)
    Given at a dose of 9 or 18mcg/kg/day by intravenous infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles.
    Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432483

Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Gary Palmer, MD Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01432483     History of Changes
Other Study ID Numbers: E7272-A001-401
Study First Received: September 7, 2011
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Cancer
ONTAK
Denileukin diftitox
persistent or recurrent disease
requiring continued delivery of essential cancer therapy

Additional relevant MeSH terms:
Denileukin diftitox
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014