Cutaneous T-cell Lymphoma, Mycosis Fungoides
Conditions
Keywords
Early-stage mycosis fungoides, Duvelisib, Topical
Brief summary
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Interventions
DRUGDuvelisib
Topical gel
Sponsors
SecuraBio
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Baseline through Day 114 | — |
| Local Skin Reactions to Duvelisib Topical Gel | After each treatment administration up to Day 114 | Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale. |
| Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel | Up to 28 days | — |
| Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel | Up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel | Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose) |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel | Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose) |
| Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Duvelisib Topical Gel | Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose) |
| Pharmacokinetics: Area Under the Curve (AUC) of Duvelisib Topical Gel | 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 | Baseline through Day 114 |
| Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score | Baseline through Day 114 |
| Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score | Baseline, Day 114 |
Countries
United States
Contacts
CONTACTMedical Director
STUDY_DIRECTORReuven Chantre, MD
Secura Bio, Inc.
Outcome results
None listed