EUCTR2014-004011-37-ES进行中（未招募）不适用
A Phase 2, Multicenter, Open-Label, Exploratory Biomarker Study of Talazoparib (BMN 673) Monotherapy in Patients with Recurrent or Metastatic Solid Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- All
入选标准
- •- 18 years of age or older
- •- Histologically confirmed breast cancer or epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer)
- •- Recurrent or metastatic disease for which talazoparib deemed an acceptable therapy by the investigator
- •- No more than 4 prior chemotherapy regimens for metastatic disease (no limit on prior hormonal therapies)
- •- Disease amenable to biopsy and willing to undergo mandatory biopsy at Screening and again at disease progression.
- •- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) resected primary ovarian tumor tissue or sufficient archival core breast tumor tissue (1 slide with 5-µm-thick sections and 9 slides with 10-µm-thick sections, minimum 20% tumor cellularity). [Note: Fresh core breast tumor tissue may be used if archival tissue is not available.]
- •- Fresh tumor biopsy collected at Screening must be of sufficient quantity with minimum 25 mm2 surface area and 40 ?m thickness (eg, 2 mm x 15 mm core) and minimum two cores.
- •- Measurable disease per RECIST 1.1
- •- Eastern Cooperative Oncology Group (ECOG) performance status ?1
- •- Adequate organ function as defined below:
- •o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?2.5x upper limit of normal (ULN) [Note: ?5xULN if liver function abnormalities are due to hepatic metastasis]
- •o Total serum bilirubin ?1.5xULN [Note: ?3xULN for Gilbert's Syndrome]
- •o Calculated creatinine clearance ?30 mL/min
- •o Hemoglobin ?9.0 g/dL with last transfusion ?14 days before first study drug
- •o Absolute neutrophil count (ANC) ?1500/mm3
- •o Platelet count ?100,000/mm3
- •- Able to take oral medications
- •- Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study-related procedures
- •- If sexually active, willing to use acceptable method of contraception (eg, double-barrier) during treatment and for 30 days after last dose of study drug
- •- If females with childbearing potential, a negative serum pregnancy test at screening and willing to have additional serum and urine pregnancy tests during the study. [Note: Females without childbearing potential include those in menopause ?2 years, with tubal ligation ?1 year before screening, or with total hysterectomy.]
- •- Willing and able to comply with all study 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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Has deleterious or pathogenic germline BRCA1 or BRCA2 mutation
- •? If received prior platinum therapy, disease progression or recurrence within 6 months after last dose of platinum
- •? HER2-positive breast cancer or inflammatory breast cancer
- •? Has not recovered from acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion criteria
- •? Prior treatment with a PARP inhibitor
- •? History of central nervous system (CNS) metastasis (except adequately treated brain metastasis that is stable and does not require corticosteroids for management of CNS symptoms)
- •? Cytotoxic chemotherapy or anti-hormone therapy ?21 days before first day of study drug (?42 days if mitomycin C was the last chemotherapy) or radiotherapy ?21 days before first day of study drug
- •? Major surgery ?21 days before first day of study drug
- •? Any investigational product or investigational medical device ?28 days before first day of study drug
- •? Prior malignancy except for any of the following:
- •o Carcinoma in situ of the cervix or non-melanoma skin cancer
- •o A cancer diagnosed and definitively treated ?5 years previously with no evidence of recurrence
- •? Known to be human immunodeficiency virus (HIV) positive
- •? Known active replicating hepatitis C or B virus
- •? Myocardial infarction ?6 months before first day of study drug, symptomatic congestive heart failure (New York Heart Association > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- •? Breast-feeding at screening or planning to become pregnant (self or partner) any time during study participation
- •? Concurrent disease or prior surgical procedure affecting talazoparib absorption
- •? Concurrent disease or condition that would interfere with study participation or safety, such as the following:
- •o Active, clinically significant infection either Grade > 2 (NCI CTCAE v4.03) or requiring parenteral antimicrobial agents ?14 days before first day of study drug
- •o Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
- •o Non-healing wound, ulcer, or bone fracture
- •o Bone marrow disorders, including myelodysplasia
- •? Known hypersensitivity to any talazoparib component
研究者
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