Who is sponsoring NCT01676831?

NCT01676831 is sponsored by Abramson Cancer Center at Penn Medicine.

What condition does NCT01676831 study?

NCT01676831 studies Cutaneous T Cell Lymphoma.

What drugs are being tested in NCT01676831?

Interventions: Topical resiquimod 0.06%, topical resiquimod 0.03%.

What is the status of NCT01676831?

NCT01676831 is currently COMPLETED.

Last reviewed 2019-07-23 · How we verify

A Phase I/IIa, Dose-Ranging Safety and Efficacy Study of Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma

NCT01676831 Phase 1/Phase 2 COMPLETED Results posted

The objective of this study is to explore the safety and the preliminary efficacy of two concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA) Cutaneous T Cell Lymphoma patients. This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products Development, FDA.

Details

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	13
Start date	2012-02
Completion	2015-09-28

Conditions

Cutaneous T Cell Lymphoma

Interventions

Topical resiquimod 0.06%
topical resiquimod 0.03%

Primary outcomes

The Number of Participants That Tolerated the Maximum Drug Dose — after 4 subjects have completed 4 weeks of study drug
After four subjects have completed at least four weeks of study drug dosing a safety review meeting will be conducted by a safety review committee. No subjects will be enrolled in the next concentration (0.03%)group until all eight have been evaluated in the 0.06% group. The safety review committee reviews all patient data including adverse events to indicate whether the patient can escalate to the highest dose.

Countries

United States