NCT03878849招募中2 期
Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK/PD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate the optimal dose of 2X-121 as single agent therapy
研究概览
简要总结
The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Age 18 years or older.
- •Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status).
- •Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
- •Patients have received no more than one line of therapy in the platinum resistant or platinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not count towards this previous line of therapy.
- •Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1
- •Performance status of ECOG ≤
- •Patients must have a life expectancy of >16 weeks.
- •Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy, or treatment with cytotoxic, hormonal, or biologic agents.
- •Adequate conditions as evidenced by the following clinical laboratory values:
- •Absolute neutrophils count (ANC) ≥ 1.5 x 103 μL
- •Hemoglobin > 9.0 g/dL
- •Platelets ≥ 100 x 103 μL
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 x ULN, unless liver metastases are present, in which case they must be ≤5 x ULN
- •Serum bilirubin ≤ 1.5 ULN
- •Creatinine ≤ 1.5 ULN
- •Blood urea nitrogen (BUN) ≤2X ULN.
- •FFPE tumor tissue should be available from the current relapse, if obtainable, otherwise the most recent archival tumor tissue. Note: Patients treated with a PARP inhibitor must have a new biopsy unless there is an archival biopsy that was done after the PARP inhibitor treatment was discontinued.
- •Negative serum pregnancy test in women of childbearing potential (WOCBP). WOCBP is defined as premenopausal women or less than 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization or hysterectomy or bilateral salpingo-oophorectomy.
- •Sexually active females of childbearing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.
排除标准
- •Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
- •Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
- •Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator.
- •Any active infection requiring parenteral or oral antibiotic treatment.
- •Known HIV positivity.
- •Known active hepatitis B or C.
- •Clinically significant cardiovascular disease:
- •Stroke within ≤ 12 months prior to day 1
- •Transient ischemic attach (TIA) within ≤ 12 months prior to day 1
- •Myocardial infarction within ≤ 12 months prior to day 1
- •Unstable angina
- •New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
- •Uncontrolled cardiac arrhythmia requiring medication
- •Other medications or conditions that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.
- •Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-
- •Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
- •Patients unable to be regularly followed for any reason (geographic, familiar, social, psychological, housed in an institution e.g., prison because of a court agreement or administrative order).
- •Patients, who are close colleagues, associates, or family members of, or in any way dependent on the sponsor or the investigator.
- •Ascites requiring drainage >500cc in the 2 weeks prior to enrolment.
研究组 & 干预措施
Drug: 2X-121 600 mg
Experimental
2X-121 will be administered daily as 600 mg (200 mg 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.
干预措施: 2X-121 (Drug)
Drug: 2X-121 800 mg
Experimental
2X-121 will be administered 800 mg (400 mg (2 x 200 mg) 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.
干预措施: 2X-121 (Drug)
结局指标
主要结局
Evaluate the optimal dose of 2X-121 as single agent therapy
时间窗: From enrollment up to approximately 2 years
To evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily compared to 800 mg daily.
次要结局
- Clinical benefit rate (CBR)(From enrollment up to approximately 2 years)
- Overall survival(From enrollment up to approximately 2 years)
- Evaluate disease control rate (DCR)(At baseline and start of each cycle, up to approximately 2 years)
- Progression free survival(From enrollment up to approximately 2 years)
- Evaluate objective response rate (ORR)(From enrollment up to approximately 2 years)
研究者
研究点 (2)
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