A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides

Official title

A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides

Overview

This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.

Interventions

• Drug Duvelisib
  Topical gel

Primary outcome measures

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Baseline through Day 114]
• Local Skin Reactions to Duvelisib Topical Gel [Time frame: After each treatment administration up to Day 114]
• Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel [Time frame: Up to 28 days]
• Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel [Time frame: Up to 28 days]

Secondary outcome measures (7)

• Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel [Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)]
• Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel [Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)]
• Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Duvelisib Topical Gel [Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)]
• Pharmacokinetics: Area Under the Curve (AUC) of Duvelisib Topical Gel [Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)]
• Proportion of Treated Lesions Achieving >50% Improvement from Baseline Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score [Time frame: Baseline through Day 114]
• Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score [Time frame: Baseline through Day 114]
• Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score [Time frame: Baseline, Day 114]

Eligibility criteria

Inclusion criteria

• Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters).
• Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug.
• Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol.

Exclusion criteria

• Have Stage IIB to IVB mycosis fungoides or Sezary syndrome.
• Have histopathologically confirmed lymph node involvement.
• Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug.
• Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period.
• Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug.
• Received electron beam irradiation within the 3 months prior to starting study drug.

Note: other protocol-defined criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Johns Hopkins University — Baltimore

Identifiers

NCT: NCT07714187 · SBI-0145-C101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗