Skip to content

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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01432483
Enrollment
Unknown
Registered
2011-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

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

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.

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.

Interventions

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.

Sponsors

Eisai Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
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

Exclusion criteria

Patients are not eligible for the Access Program with denileukin diftitox if they: • Are not currently on denileukin diftitox therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026