NCT03600441进行中（未招募）2 期
Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 139
- 试验地点
- 15
- 主要终点
- Clinical effect of abexinostat
研究概览
简要总结
This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.
详细描述
Patients will be evaluated for objective response, Duration of Response (DOR), Progression Free Survival (PFS), Clinical Benefit Rate (CBR), Overall survival (OS), safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and changes in health related quality of life. Patients may receive treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. An independent data safety monitoring committee (iDMC) will evaluate the data pertaining to the futility and decide whether the study should stop or continue to the second stage. If the study continues to the second stage, a total of 139 patients will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.
- •Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma.
- •Has follicular lymphoma that has relapsed after (progressed after 6 months from the start of therapy) or is refractory to the last line of therapy (no response or progression within 6 months from the start of therapy) and needs treatment (must have at least 1 lymph node or extranodal lymphoid malignancy radiologically measuring ≥ 3 cm in its longest diameter).
- •Female patients must fulfil the following criteria:
- •a. Be of non-childbearing potential, defined as follows: i. Postmenopausal (ie, ≥ 1 year without any menses) prior to Screening, or ii. Documented surgically sterile (≥ 1 month prior to Screening)
- •Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose.
- •Use highly effective forms of birth control (women of childbearing potential only), which include the following:
- •i. Consistent and correct use of established oral contraception ii. Established intrauterine device or intrauterine system iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- •Female patients must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose.
- •Male patients and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose.
- •Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose.
排除标准
- •Has diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B-cell lymphoma
- •Has a history of central nervous system lymphoma (either primary or secondary).
- •Has had prior treatment with abexinostat.
- •Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment
- •Has any types of cardiac impairment at the time of enrollment
- •Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer
- •Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 3 years
研究组 & 干预措施
Abexinostat
Experimental
Abexinostat tablets will be administered orally at 80 mg (4 × 20 mg tablets) BID (twice a day) 4 hours apart for 7 days in a "one week on, one week off" schedule (on Days 1 to 7 and Days 15 to 21 of each 28-day cycle).
干预措施: Abexinostat (Drug)
结局指标
主要结局
Clinical effect of abexinostat
时间窗: Time frame up to 100 months
Complete response (CR) or partial response (PR) according to the Lugano 2014 criteria as determined by an Independent Review Committee (IRC).
次要结局
- Incidence of non-serious adverse events(At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
- Clinical Benefit(At the end of cycle 2 (each cycle is 28 days) and through study completion, assessed up to 100 months.)
- Duration of response(At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
- Incidence of serious adverse events(At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
- Incidence of adverse events(At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
- Change in the interval corrected for heart rate (QTc) interval(At the end of cycle 2 (each cycle is 28 days) or from date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
- Progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
- Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months)
研究者
研究点 (15)
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