EUCTR2018-004186-14-ES进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 177
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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.
- •9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •10. Adequate organ and bone marrow function meeting the following criteria at the Screening Visit:
- •? Absolute neutrophil count (ANC) = 1,500 cells/mm3.
- •? Platelet count = 100,000/mm3.
- •? Hemoglobin = 9 g/dL.
- •? AST or ALT = 2.5 × upper limit of normal (ULN) (or = 5 × ULN in the context of liver metastasis).
- •? Total bilirubin = 1.5 × ULN.
- •? Serum creatinine = 1 × ULN; creatinine clearance = 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •? Albumin = 3 g/dL (= 30 g/L) .
- •11. If patient has undergone surgery of the gastrointestinal or hepatobiliary tract, adequate absorption as evidenced by: albumin = 3.0 g/dL, controlled pancreatic insufficiency (if present), and lack of malabsorption.
- •12. Able to swallow and retain oral medication and does not have uncontrolled emesis.
- •13. Able to comply with protocol requirements.
- •14. Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential must use appropriate precautions to avoid pregnancy, defined as of nonchildbearing potential (i.e., postmenopausal or permanently sterilized) or using highly effective contraception with low user-dependency, for at least 3 months after the last dose of study drug. A woman is postmenopausal if it is more than 12 months since her last menstruation, without an alternative medical cause. Accepted methods of permanent sterilization methods are hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy. Accepted methods of highly effective contraception with low user-dependency are:
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.
- •8. Peripheral neuropathy from any cause > Grade 1.
- •9. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with screening visit through 90 days after the last dose of trial treatment.
- •10. 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 enrollment.
- •11. Patient has a clinically significant uncontrolled condition(s) or which in the opinion of the Investigator may confound the results of the trial or interfere with the patient’s participation, including but not limited to:
- •? Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
- •? Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg despite optimal management). Patients will be considered eligible if hypertension is treated and controlled during Screening.
- •? Active infection that requires parenteral antibiotics.
- •? Bowel obstruction or gastric outlet obstruction.
- •? Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •12. Untreated parenchymal central nervous system metastases.
- •13. Any other concurrent cancer or a history of another inva
研究者
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