Trial Search Results

A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

The purpose of this research trial is to see how safe and how well the topical gel CD11301 (topical means “applied to the skin”) works to treat CTCL in its early stages. The study will gather information to measure if any quantity of the study drug reaches the blood (ie. How much, if any, of the drug is absorbed from the skin) following topical application. The study will also evaluate whether the gel applied to one part of the body will have an effect in a non-treated area affected by your T-cell lymphoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Galderma R&D

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Drug: CD11301 0.03%
  • Drug: CD11301 0.06%

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months

   - Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3
   distinct lesions

Exclusion Criteria:

   - CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary
   cells or CD8+ or large cell transformation or Progressive CTCL

   - History of autoimmune disease

   - Laboratory test values at screening outside of the normal range and judged clinically
   significant by the investigator

   - Current participation in another clinical trial of a drug or device or past
   participation within 4 weeks before Baseline or subject is in exclusion period from a
   previous clinical trial

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sydney Yee
650-721-6118
Not Recruiting