NCT02213861Unknown2 期
A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
TetraLogic Pharmaceuticals5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).
详细描述
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histological confirmation of CTCL; a documented verifiable biopsy report is required
- •Documented clinical stage IA, IB or IIA CTCL
- •Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
- •ECOG performance status of 0-2
排除标准
- •CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
- •Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
- •Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
- •Any prior history of hematologic malignancy (other than CTCL) within past 5 years
- •CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
- •Prior or concurrent central nervous system (CNS) metastases
- •History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator
- •Evidence of active Hepatitis B or C or HIV
- •Circulating atypical cells of clinical significance
研究组 & 干预措施
1.0% SHAPE Gelled Solution once daily
Experimental
干预措施: SHAPE (Drug)
0.5% SHAPE Gelled Solution twice daily
Experimental
干预措施: SHAPE (Drug)
1.0% SHAPE Gelled Solution twice daily
Experimental
干预措施: SHAPE (Drug)
结局指标
主要结局
Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
时间窗: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
次要结局
- Patient assessment of pruritis using a Visual Analog Scale (VAS)(Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).)
- modified Composite Assessment of Index Lesion Severity (CAILS)(Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).)
- Skindex-29 Quality of Life Tool(Every 4 weeks for 26 weeks)
- modified Severity Weighted Assessment Tool (mSWAT)(Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).)
研究者
研究点 (5)
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