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

ConditionsMycosis FungoidesCutaneous T-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecuraBio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Duvelisib

    Drug

    Topical gel

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: DuvelisibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time frame
Baseline through Day 114
2

Local Skin Reactions to Duvelisib Topical Gel

Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.

Time frame
After each treatment administration up to Day 114
3

Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel

Time frame
Up to 28 days
4

Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel

Time frame
Up to 28 days

Secondary outcomes

1

Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel

Time frame
Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
2

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel

Time frame
Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SecuraBio

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: