EUCTR2013-004405-30-GB进行中（未招募）1 期
A Phase 1 Study of Onapristone in Patients with Advanced Castration-resistant Prostate Cancer - Onapristone prostate phase 1-2
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
- 75
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
- 性别
- Male
入选标准
- •1. Male patients, 18 years of age or greater;
- •2. Histologically confirmed adenocarcinoma of the prostate (without neuroendocrine differentiation or small cell features).
- •3.In stage 2, for the abiraterone combination arm patients’ disease should have progressed on abiraterone and for the monotherapy arm patients’ disease should have progressed on previous abiraterone or enzalutamide.
- •4.For Stage 2 only:
- •a. for patients recruited to the abiraterone-onapristone combination arm, if biopsy is feasible (non-bone lesions are preferred), it should be performed while the patient is on abiraterone
- •b. for additional patients who are being recruited as T878A positive for the combination arm, the T878A mutation must be confirmed on plasma testing or tumor tissue
- •c. for patients in the monotherapy arm, if biopsy is feasible (non-bone lesions are preferred), it should be performed within 6-weeks prior to starting study treatment
- •d. if biopsy is not feasible the PI must have initiated the request for archival tissue for central analysis;
- •5. Metastatic or recurrent inoperable disease after previous surgery, radiation therapy, and/or chemotherapy;
- •6. For patients in Stage 1 and for patients in Stage 2 who will receive combination therapy with onapristone
- •and abiraterone: no more than one prior chemotherapy regimens for CRPC ( single agent docetaxel rechallenge will be regarded as one line of chemotherapy); for patients in Stage 2 who will receive onapristone monotherapy: no prior chemotherapy is allowed;
- •7. Disease that has progressed by PSA or radiologically on abiraterone or enzalutamide. Disease progression for study entry is defined as one or both of:
- •PSA progression defined by a minimum of two rising PSA levels with an interval of =1 week between each determination and a value = 2 µg/L (2 ng/mL);
- •Radiological progression per RECIST 1.1;
- •8. For patients recruited to the abiraterone-onapristone combination arm, progression on abiraterone as their last line of treatment is required with discontinuation up to 8 weeks prior to date of consent and treatment with continuous abiraterone for a minimum of 12 weeks.; patients recruited to the monotherapy arm may initiate study treatment immediately upon discontinuation of abiraterone or enzalutamide;
- •9.The PSA value at screening and baseline should be = 2 µg/L (2 ng/mL);
- •10. For onapristone monotherapy, corticosteroid discontinuation >4 weeks or >2 weeks with normal adrenal function confirmed by an ACTH stimulation test. For the combination onapristone – abiraterone arm, prednisolone 5mg BID and no other steroid regimen allowed for 2 weeks prior to treatment initiation;
- •11. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration);
- •For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
- •12. Serum testosterone level < 1.7 nmol/L (50 ng/dL);
- •13. Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks;
- •14. ECOG performance status 0-2;
- •15. Life expectancy = 3 months;
- •16. Willing and able to sign written informed consent per ICH-GCP, the local regulatory requirements, and local data protection laws prior to study-specific screening procedures.
- •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 15
排除标准
- •1. Serum creatinine >1.5 ULN;
- •2. On ECG a QTc(F) interval >480 msec or any clinically significant cardiac rhythm abnormalities;
- •3. Liver function tests documented within the screening period and/or at baseline:
- •a.Total bilirubin > ULN (except in patients diagnosed with Gilbert’s disease);
- •b. Alkaline phosphatase > 2.5 x UNL, unless test for alkaline phosphatase isoenzymes is elevated only for bone isoenzyme;
- •c. ALT/AST > UNL or > 2.5 x UNL in case of liver metastases;
- •d. Grade = 2 AST, ALT or bilirubin elevation on prior abiraterone treatment (for Stage 2 combination arm only)
- •4. Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, and hemoglobin < 5.6 mmol/L (9 g/dL) and no growth factors or blood transfusions within 7 days of these values;
- •5. Serum albumin < 25 g/L (2.5 g/dL);
- •6. Known positive virology/serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B (surface antigen), or hepatitis C (testing not required);
- •7. Chronic inflammatory liver condition. History or clinical evidence of any liver or biliary pathology including cirrhosis, infectious disease, inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis, primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract, spasm of sphincter of Oddi, biliary cyst or biliary atresia;
- •8. Patients with any other prior malignancy are not allowed except for:
- •a. Adequately treated basal cell or squamous cell skin cancer;
- •b. Adequately treated Stage I or II cancer from which the patient is currently in complete remission;
- •c. Other cancer from which the patient has been disease-free for 2 years;
- •9. For stage 1 only: Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy. Prior long-term corticosteroids must be stopped =4 weeks or >2 weeks if normal adrenal function is confirmed by an ACTH stimulation test prior to start of study drug;
- •10. History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating; e.g., active or clinically significant history of disease involving a major organ system—vascular, cardiac, uncontrolled hypertension, pulmonary, gastrointestinal, hematologic, neurologic, neoplastic, renal, endocrine or immunodeficiency, or clinically significant active psychiatric disorders;
- •11. Used any prescription medication during the prior 2 weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating, specifically inhibitors or inducers of cytochrome P450 (CYP)3A4;
- •12. Received an investigational product or been treated with an investigational device within 30 days prior to first drug administration, or plans to start any other investigational product or device study within 30 days after last drug administration;
- •13. Received prior therapies within the following time period prior to receipt of first dose of study drug (Day 1, without withdrawal response and with no plans to initiate any of these during study:
- •a. Ketoconazole or bicalutamide within 6 weeks;
- •b. Systemic hormone therapy, chemotherapy, targeted therapies, antibodies within 4 weeks excluding abiraterone in abiraterone-onapristone combination arm;
- •c. Fractionated radiotherapy within 3 weeks;
- •d. Single fraction of radiotherapy within 2 weeks;
- •e. Radionuclide therapy within 8 weeks;
- •f. Brachytherapy Pd-103 implant with
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