A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/25/2019 |
Start Date: | December 19, 2017 |
End Date: | August 2019 |
Contact: | Galderma R&D |
Email: | frnceclinicaltrials@galderma.com |
Phone: | 817-961-5120 |
A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA
To assess the efficacy, safety and pharmacokinetics in subjects treated with CD11301 gel vs.
placebo for early stage CTCL (IA, IB, or IIA).
placebo for early stage CTCL (IA, IB, or IIA).
To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in
the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.
the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.
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
We found this trial at
13
sites
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