Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.

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Detailed Description

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Conditions

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Lymphoma, T-Cell, Cutaneous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo for SHAPE (SHP-141)

placebo for SHAPE (SHHP-141) topical gelled solution

Group Type PLACEBO_COMPARATOR

placebo for SHAPE (SHP-141)

Intervention Type DRUG

topical gelled solution

SHAPE (SHP-141) 0.1%BID

SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly

Group Type EXPERIMENTAL

SHAPE (SHP-141) 0.1% BID

Intervention Type DRUG

topical gelled solution

SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly

Group Type EXPERIMENTAL

SHAPE (SHP-141) 0.5% BID

Intervention Type DRUG

topical gelled solution

SHAPE (SHP-141) 1.0% BID

SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly

Group Type EXPERIMENTAL

SHAPE (SHP-141) 1.0% BID

Intervention Type DRUG

topical gelled solution

Interventions

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placebo for SHAPE (SHP-141)

topical gelled solution

Intervention Type DRUG

SHAPE (SHP-141) 0.1% BID

topical gelled solution

Intervention Type DRUG

SHAPE (SHP-141) 0.5% BID

topical gelled solution

Intervention Type DRUG

SHAPE (SHP-141) 1.0% BID

topical gelled solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histopathologically confirmed CTCL; a documented verifiable biopsy report is required.
* Documented clinical Stage IA, IB, or IIA CTCL.
* Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy.
* ECOG performance status of 0-2.

Exclusion Criteria

* CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL.
* Severe pruritus requiring systemic or topical treatment.
* Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease).
* Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively).
* Any prior history of a hematologic malignancy (other than CTCL).
* History of or current major renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator.
* Evidence of active Hepatitis B or C or HIV.
* Circulating atypical cells \>5%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No