NCT05636111招募中1 期
Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.
详细描述
Primary Objectives:
- To identify dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of the combination of paclitaxel/bevacizumab/lurbinectedin in women with platinum resistant ovarian cancer.
- To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab/lurbinectedin.
Secondary Objectives:
- To assess objective response (OR) and duration of response (DOR).
- To assess clinical benefit rate (CBR), defined as proportion of patients with OR or stable disease (SD) > 4 months.
- To estimate progression free survival (PFS) and overall survival (OS) for at least 12 months
Exploratory Objectives:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will be assessed within 28 days of starting study treatment:
- •Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines.
- •Age ≥ 18 years at time of study entry
- •Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory* or platinum resistant** disease are allowed. Prior anti-VEGF targeted therapy (e.g. bevacizumab, VEGF TKI's) is allowed.
- •Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose.
- •Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy
- •Prior Therapy: Unlimited prior systemic therapies are allowed.
- •ECOG performance status of 0-1 (Appendix A)
- •Adequate normal organ and marrow function as defined below.
- •Hemoglobin ≥9.0 g/dL.
- •Absolute neutrophil count (ANC) > 1500/mm
- •Platelet count ≥100 x 109/L
- •Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- •AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.
- •Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- •Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- •Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
- •Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- •Measurable disease by RECIST v1.1
排除标准
- •Exclusion criteria will be assessed within 28 days of starting study treatment. Patients meeting any of the following exclusion criteria are not eligible to enroll in this study.
- •1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.
- •2. Use of an anti-cancer treatment drug or investigational drug during the last 28 days or 5 half-lives (whichever is shorter) prior to cycle 1 day 1. A minimum of 10 days between termination of prior treatment and administration of study treatment is required.
- •3. Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as inflammatory bowel disease, bowel obstruction, history of bowel obstruction, or overt bowel involvement by tumor.
- •4. Patients who are pregnant or lactating.
- •5. Major surgery \2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
- •10. Serious psychiatric or medical conditions that could interfere with treatment;
- •11. Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1
- •12. Concurrent therapy with approved or investigational anticancer therapeutic other than steroids.
- •13. Patients with coagulation problems and active bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)
- •14. Patients with symptomatic brain lesions
- •15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- •16. History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type.
- •17. Non-healing wound, ulcer or bone fracture.
- •18. Known hypersensitivity to lurbinectedin, paclitaxel, bevacizumab or excipients.
研究组 & 干预措施
Dose Escalation and Dose Expansion
Experimental
Pariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
干预措施: Paclitaxel (Drug)
Dose Escalation and Dose Expansion
Experimental
Pariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
干预措施: Lurbinectedin (Drug)
Dose Escalation and Dose Expansion
Experimental
Pariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点
研究者
研究点 (1)
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