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NCT01432483 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01432483
Other study ID # E7272-A001-401
Secondary ID
Status No longer available
Phase N/A
First received September 7, 2011
Last updated January 22, 2015

Study information
Verified date January 2015
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Inc.
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