A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Corcept Therapeutics Incorporated0 个研究点目标入组 177 人2019年5月3日

适应症Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061344Term: Peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
发起方: Corcept Therapeutics Incorporated
入组人数: 177
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2019年5月3日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

研究者

发起方

Corcept Therapeutics Incorporated

入排标准

入选标准

•1\. Signed and dated IRB/IEC\-approved informed consent form (ICF) prior to study\-specific screening procedures.
•2\. Female patients aged \= 18 years old at time of consent.
•3\. Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous and borderline histologic subtypes are excluded.
•4\. Received at least one line of therapy with progression within 6 months after platinum\-based therapy, persistent disease at the completion of primary platinum\-based therapy, or PD during platinum\-based therapy. Patients with primary platinum resistance (progression after first\-line chemotherapy) are considered eligible.
•5\. Measurable or non\-measurable disease by RECIST v1\.1:
•? Previously irradiated lesions are not allowed as measurable disease, unless there is documented evidence of progression in the lesions.
•? To be eligible with non\-measurable disease, patients must have evaluable disease with CA\-125 of at least twice the upper limit of the reference range (or CA\-125 \= 70 U/mL) along with radiographically evaluable disease by CT/MRI.
•6\. Availability and consent to provide tumor tissue for GR immunohistochemistry (archival or recent biopsy).
•7\. Up to 2 prior chemotherapeutic or myelosuppressive regimens for recurrent disease (not including maintenance therapy such as single\-agent bevacizumab).
•8\.Appropriate to treat with nab\-paclitaxel, in the opinion of the Investigator.

排除标准

•1\. Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that in the opinion of the Investigator has not resolved to Grade 1 or less prior to randomization.
•2\. Any major surgery within 4 weeks prior to randomization. If subject received major surgery including (curative or palliative surgery), they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•3\. Treatment with the following prior to randomization:
•? Concurrent treatment with other anticancer therapy including other chemotherapy, immunotherapy, radiotherapy, chemo\-embolization, targeted therapy, an investigational agent or the non\-approved use of a drug or device within 28 days before the first dose of study drug.
•? Hormonal anticancer therapies within 7 days of the first dose of study drug.
•? Systemic, inhaled, or prescription strength topical corticosteroids within 21 days of the first dose of study drug. Short courses (\= 5 days) for non\-cancer\-related reasons are allowed if clinically required (such as prophylaxis for CT).
•4\. Received radiation to more than 25% of marrow\-bearing areas.
•5\. Toxicities of prior therapies (except alopecia) that have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI\-CTCAE) v5\.0 \= Grade 1\.
•6\. Requirement for treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ transplantation).
•7\. History of severe hypersensitivity or severe reaction to either study drug.