A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With Itacitinib (INCB039110) in Subjects With Relapsed or Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)
研究概览
简要总结
A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Men and women, aged 18 years or older
- •Histologically confirmed diagnosis of classical HL
- •Must be relapsed or refractory after autologous stem cell transplant (ASCT) and/or 2 or more prior chemotherapy regimens
- •Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin
- •Eastern Cooperative Oncology Group (ECOG) 0 to 2
排除标准
- •Laboratory parameters not within the protocol-defined range
- •Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
- •Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
- •Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy
- •Received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug
- •History of lymphoma involving the central nervous system
- •Evidence of active or prior hepatitis infection.
研究组 & 干预措施
INCB040093 Monotherapy
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
干预措施: INCB040093 Monotherapy (Drug)
INCB040093 and itacitinib (INCB039110) Combination Therapy
Subjects allocated to Group B will be given INCB040093 BID in combination with itacitinib SR tablets. The dose of itacitinib will be orally given once daily (QD). Doses should be taken in the morning on an empty stomach if possible.
干预措施: INCB040093 (Drug)
INCB040093 and itacitinib (INCB039110) Combination Therapy
Subjects allocated to Group B will be given INCB040093 BID in combination with itacitinib SR tablets. The dose of itacitinib will be orally given once daily (QD). Doses should be taken in the morning on an empty stomach if possible.
干预措施: itacitinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)
时间窗: Measured every 9 weeks from baseline until progression (estimated to be 12 months)
Evaluate the efficacy of INCB040093 as monotherapy and when given in combination with itacitinib by assessing the objective response rate (ORR) determined by an independent review committee.
次要结局
- Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria(Week 36 disease evaluation)
- To evaluate the duration of response (DOR)(Week 36 disease evaluation)
- Percentage of participants reporting adverse events in the monotherapy group(every 3 weeks for the duration of participation in the study [estimated to be 12 months])
- Percentage of participants reporting adverse events in the combination therapy group(every 3 weeks for the duration of participation in the study [estimated to be 12 months])
- To evaluate the progression-free survival (PFS)(Week 36 disease evaluation)