Clinical trial NCT01433731: Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, T-Cell, Cutaneous
Keywords: CTCL
Cutaneous T-Cell Lymphoma
Lead sponsor: TetraLogic Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: The Leukemia and Lymphoma Society
name: Therapeutics, Inc.
name: Veristat, Inc.
name: PPD Development, LP
First posted: 2011-09-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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%

Primary outcomes:
measure: Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)
timeFrame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern University Dept of Dermatology
state: Illinois
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Gahanna
country: United States
facility: Ohio State University
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Northwestern University
name: Joan Guitart, MD
role: PRINCIPAL_INVESTIGATOR
References: