A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA) - ROSELLA

Corcept Therapeutics Incorporated0 个研究点目标入组 360 人开始时间: 2023年1月17日最近更新: 2024年8月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Corcept Therapeutics Incorporated
入组人数: 360

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: Female

入选标准

•1. Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.
•2. Female patients aged =18 years old at time of consent.
•3. Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (high-grade endometroid or carcinosarcoma with =30% endometroid epithelial tumor component are eligible).
•4. Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression <6 months from completion of a platinum-containing therapy).
•5. Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
•6. Has a life expectancy of =3 months.
•7. At least one lesion that meets the definition of measurable disease by RECIST v.1.1 (previously irradiated lesions not allowed as measurable disease unless there is documented evidence of progression in the lesions).
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•9. Able to comply with protocol requirements.
•10. Able to swallow and retain oral medication and does not have uncontrolled emesis.
•11. Received at least 1 but =3 lines of prior systemic anticancer therapy. At least 1 prior line of platinum therapy is required and prior treatment with bevacizumab is required.
•12. Has adequate organ function meeting the protocol-defined laboratory-test criteria.
•13. Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
•14. COVID-19 approved vaccines (or vaccines with regulatory health authority’s emergency use authorization / conditional marketing authorization) are accepted concomitant medications when recommended by the Investigator. Exceptions may apply should the Investigator and the Medical Monitor determine that the vaccine will interfere with the objectives of the study.
•Please refer to the protocol for complete list of inclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

排除标准

•1. Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to =Grade 1 prior to randomization.
•2. Has had any major surgery within 4 weeks prior to randomization. If patient 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. Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
•4. Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed =1 month of the last dose of first-line platinum-containing chemotherapy.
•5. Have not received prior bevacizumab treatment.
•6. Has been treated with the following prior to randomization:
•- Chemotherapy, immunotherapy, investigational agent etc. treatments for disease under study within 28 days before first dose of study drug.
•- Radiotherapy not completed at least 2 weeks prior to first dose of study drug.
•- Hormonal anticancer therapies within 7 days of first dose of study drug.
•- Systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
•7. Has received wide-field radiation to more than 25% of marrow-bearing areas.
•8. Has toxicities of prior therapies that have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, =Grade 1.
•9. Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ transplantation).
•10. Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
•11. Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
•12. Has peripheral neuropathy from any cause >Grade 1.
•13. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the screening visit through at least 1 month after the last dose of relacorilant or 6 months after the last dose of nab-paclitaxel whichever is the longest.
•14. Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient’s safety or participation.
•15. Has current chronic/active infection with Human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus, including patients with chronic or active hepatitis B as diagnosed by serologic tests are excluded from the study. In equivocal cases, hepatitis B or C polymerase chain reaction may be performed and must be negative for randomization.
•16. Has any untreated or symptomatic central nervous system (CNS) metastases.
•17. Patients with a history of other malignancy within 3 years prior to randomization.
•18. Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
•19. Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
•20. Has received a live vaccine within 30 days of prior to the study start date.
•Please refer to the protoco

研究者

发起方

Corcept Therapeutics Incorporated

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