Phase 1
N=18
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
Lymphoma, T-Cell, Cutaneous
Bottom Line
View on ClinicalTrials.gov: NCT01433731 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) — 27; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- placebo for SHAPE (SHP-141) (Drug); SHAPE (SHP-141) 0.1% BID (Drug); SHAPE (SHP-141) 0.5% BID (Drug); SHAPE (SHP-141) 1.0% BID (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TetraLogic Pharmaceuticals
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) |
27; 0 | — |
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%
Data sourced from ClinicalTrials.gov (NCT01433731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.