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

TetraLogic Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lymphoma, T-Cell, Cutaneous

Treatments: Drug: SHAPE (SHP-141) 1.0% BID; Drug: placebo for SHAPE (SHP-141); Drug: SHAPE (SHP-141) 0.1% BID; Drug: SHAPE (SHP-141) 0.5% BID

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01433731

SHP-141-001

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 4 patient groups, including a placebo group

placebo for SHAPE (SHP-141)

Placebo Comparator group

Description:

placebo for SHAPE (SHHP-141) topical gelled solution

Treatment:

Drug: placebo for SHAPE (SHP-141)

SHAPE (SHP-141) 0.1%BID

Experimental group

Description:

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

Treatment:

Drug: SHAPE (SHP-141) 0.1% BID

SHAPE (SHP-141) 0.5% BID

Experimental group

Description:

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

Treatment:

Drug: SHAPE (SHP-141) 0.5% BID

SHAPE (SHP-141) 1.0% BID

Experimental group

Description:

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

Treatment:

Drug: SHAPE (SHP-141) 1.0% BID