| Methods |
This is a phase 1b multicentre, double‐blind, placebo‐controlled, randomised trial in stage IA‐IIA CTCL to assess safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy with SHP‐141 applied twice daily to index lesions (maximum 5% of body surface area) for 28 days. |
| Participants |
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.
Exclusion Criteria
CTCL with histological 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 hematological malignancy (other than CTCL) Circulating atypical cells >5%
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| Interventions |
This study had 4 treatment arms.
placebo for SHAPE (SHHP‐141) topical gelled solution SHAPE (SHP‐141) topical gelled solution at 0.1% concentration twice weekly SHAPE (SHP‐141) topical gelled solution at 0.5% concentration twice weekly SHAPE (SHP‐141) topical gelled solution at 1.0% concentration twice weekly
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| Outcomes |
Outcomes of the trial
Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo‐ or hyperpigmentation, each on a scale of 0 to 8; and lesion size Complete response (CR): 100% decrease in CAILS score Partial response (PR): 50% ‐ 99% decrease in CAILS score Stable disease (SD): < 25% increase to < 50% decrease in CAILS score Progressive disease (PD) ≥ 25% increase in CAILS score
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| Notes |
This was a meeting abstract. Additional information was sought but we received no response.
This study is NCT01433731. |
