NCT07714187尚未招募1 期
A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides
SecuraBio1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2027年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel
研究概览
简要总结
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel
时间窗: Up to 28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline through Day 114
Local Skin Reactions to Duvelisib Topical Gel
时间窗: 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
时间窗: Up to 28 days
次要结局
- 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)
研究者
研究点 (1)
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