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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, T-Cell, Cutaneous

Thank you

Trial Information

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


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%

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)

Outcome Time Frame:

Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42

Safety Issue:

Yes

Principal Investigator

Joan Guitart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

SHP-141-001

NCT ID:

NCT01433731

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Lymphoma, T-Cell, Cutaneous
  • CTCL
  • Cutaneous T-Cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Stanford UniversityStanford, California  94305
Cleveland ClinicCleveland, Ohio  44195
Northwestern University Dept of DermatologyChicago, Illinois  60611