ACTRN12619000583145撤回2 期
A Phase II, Signal-Seeking Trial of the Clinical Benefit Rate Associated with Pamiparib in Subjects with Germline or Somatic BRCA1/2 High Grade Serous Ovarian Cancer or carcinosarcoma who have progressed on P-gp substrate chemotherapy or PARP inhibitors with the Presence of an ABCB1 Fusion and the Absence of a BRCA1/2 Reversion
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Inclusion Criteria - Pre Screening
- •1.Patient has provided written informed consent for pre-screening
- •2.Patient is able to comply with the study protocol and follow-up procedures, in the Investigator’s judgement
- •3.Patient is female aged a minimum of 18 years at time of consent
- •4.ECOG performance status 0-2
- •5.Patient has the ability to take oral medications without medical history of malabsorption or other chronic gastrointestinal disease, or other conditions that may harm compliance and/or absorption of the study agent
- •6.Patients with a histopathological diagnosis of HGSC or carcinosarcoma of the ovary (including primary peritoneal cancers and fallopian tube cancers) as defined by histological diagnosis and immunohistochemistry (IHC) and with a germline or somatic BRCA1/2 mutation:
- •Mixed histologies are allowed provided that >80% of the primary tumour is a high grade serous ovarian carcinoma based on diagnostic pathology review and IHC profile
- •7.Patients with progressive disease defined by GCIG CA-125 and/or RECIST v1.1 criteria after 3 or more lines of chemotherapy or after progression on a P-gp substrate PARP inhibitor
- •Patients may continue on treatment as per standard of care by their usual clinician while awaiting the results of pre-screening with no impact on usual care.
- •Patients who have been treated with both substrate PARPi and substrate chemotherapy will be considered eligible for either cohort 1 or cohort 2 based on the therapy they have most recently progressed on (cohort 1 is progression on PARPi and cohort 2 is progression on chemotherapy)
- •8.Disease that is amenable to a biopsy and/or ascitic drainage
- •Lesions intended to be biopsied should not be target lesions with the preference of the biopsy site having progressed on most recent imaging where clinically safe and feasible
- •9.Patient has a life expectancy > 12 weeks
- •10.Patient has consented to the collection and use of their fresh tumour biopsies and/or ascites samples
- •Inclusion Criteria - Main Study
- •1.Patient has provided written informed consent for the main PRECISE study
- •2.Patient continues to meet all pre-screening inclusion criteria
- •3.Patient has an ABCB1 fusion(s) and the absence of BRCA1/2 reversions
- •4.Patient has platinum sensitive or platinum resistant HGSC
- •Patients who are refractory (progress during or within 4 weeks) to second or subsequent lines of platinum-based chemotherapy are eligible.
- •Patients who are primary platinum refractory (progress during or within 4 weeks of first line chemotherapy) are considered ineligible.
- •5.Recurrent disease that is measurable according to RECIST v1.1 or evaluable disease using CA-125 according to GCIG criteria
- •6.Adequate haematologic and end-organ function, as defined by the following laboratory results (obtained within 7 days prior to registration to the main study:
- •Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- •Platelet count greater than or equal to 100 x 109/L
- •Haemoglobin (Hb) greater than or equal to 90 g/L (greater than or equal to 28 days after growth factor support or transfusion)
- •Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 by the Modification of Diet in Renal Disease study equation (MDRD STUDY EQ; www.mdrd.com)
- •Total serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 4 x ULN, if Gilbert’s syndrome or if indirect bilirubin concentrations s
排除标准
- •1. Patients who have received chemotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or herbal remedies less than or equal to 5 half-lives if the half-life is known, less than or equal to 14 days if not known, prior to registration to the main study
- •Bisphosphonate and denosumab use are allowed on study, if administered at a stable dose > 28 days prior to registration to the main study
- •2. The use or anticipated need for food or drugs known to be strong CYP3A inducers less than or equal to 5 half-lives if the half-life is known or less than or equal to 14 days if not known prior to registration to the main study
- •3. Major surgical procedure, open biopsy, or significant traumatic injury less than or equal to 14 days prior to registration to the main study, or anticipation of need for major surgical procedure during the course of the study
- •Placement of vascular access device is not considered major surgery.
- •4. Prior radiation therapy less than or equal to 14 days prior to registration to the main study to non-target lesions. Patients who have received palliative radiotherapy of non-target lesions for local symptom control > 14 days prior to registration to the main study must have stabilisation of any AEs or a return to baseline prior to the registration to the main study
- •5. Leptomeningeal disease or uncontrolled, untreated brain metastases
- •6. Patients with a history of treated and asymptomatic brain metastases are eligible, provided they meet all of the following:
- •Only supratentorial metastases
- •Brain imaging at screening without evidence of interim progression
- •No ongoing requirement for corticosteroids as therapy for brain metastases
- •o Anticonvulsants at a stable dose allowed (except for contraindicated medications carbamazepine and phenytoin)
- •No stereotactic radiation or whole-brain radiation prior to registration to the main study
- •7. Any of the following cardiovascular criteria:
- •Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, less than or equal to 28 days prior to registration to the main study
- •Symptomatic pulmonary embolism less than or equal to 28 days prior to registration to the main study
- •Any history of acute myocardial infarction less than or equal to 6 months prior to registration to the main study
- •Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV less than or equal to 6 months prior to registration to the main study
- •Any event of ventricular arrhythmia greater than or equal to Grade 2 in severity less than or equal to 6 months prior to registration to the main study. Any history of cerebrovascular accident (CVA) less than or equal to 6 months prior to registration to the main study
- •8. Active infection requiring systemic treatment, acute/viral hepatitis or active chronic hepatitis B or C or active tuberculosis
- •Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is > 500 IU/mL or patients with active hepatitis C should be excluded. Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled.
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