ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.
详细描述
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer. The study will evaluate whether this regimen is safe. The study will also evaluate whether the regimen can reduce the amount of cancerous cells in your body. If you agree, you will be treated with VS-6063 by mouth, as well as carboplatin and paclitaxel infusions. Carboplatin and paclitaxel are approved by the FDA for the treatment of ovarian cancer. VS-6063 is considered experimental because it is not approved by the FDA for the treatment of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, diagnosed within 6 months of completing their most recent platinum-containing chemotherapy.
- •Patients with the following histologic cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
- •Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, noncytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
- •Must have NOT received more than two total prior lines of cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens.
- •May have received one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small molecule inhibitors of signal transduction.
- •Women of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception.
- •Must have adequate:
- •Bone marrow function
- •Renal function
- •Hepatic function
- •Neurologic function
- •Recovered from effects of recent surgery, radiotherapy, or chemotherapy. All persistent clinically significant toxicities from prior chemotherapy must be less than or equal to Grade
- •Free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
- •Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.
排除标准
- •Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma.
- •Known second primary or prior malignancy diagnosed within 5 years of study start date (other than previously treated non-melanoma skin cancer).
- •Current treatment with chemotherapy or radiation therapy. Any prior therapy directed at the malignant tumor, including biologic and immunologic agents, must be discontinued at least three weeks prior to registration.
- •History of treatment with known kinase inhibiting agents.
- •History of gastrointestinal fistula, hemorrhage, perforation or peptic ulcer disease.
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
干预措施: VS-6063 (Drug)
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
干预措施: VS-6063 (Drug)
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 4 years
ORR by RECIST 1.1.
To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
时间窗: 4 years
Measured Via Adverse Events
Dose-Limiting Toxicity
时间窗: 28 days
Safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Objective Response Rate (ORR)
时间窗: 4 years
次要结局
- progression free survival (PFS)(4 years)
- overall survival (OS)(4 years)
- To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)(4 years)
- To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)(4 years)
- To Assess the Toxicity and Adverse Event Profile of VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy (Measured Via Adverse Events)(4 years)
- To Describe Health-related Quality-of-life (QoL) Outcomes of Patients Receiving VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy. (Measured Via Questionnaire)(4 years)
- Progression Free Survival (PFS)(4 years)
- Overall Survival (OS)(4 years)
研究者
Michael McHale
Clinical Professor
University of California, San Diego