Recurrent or Metastatic Solid Tumors MedDRA version: 18.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: talazoparib
Product Code: talazoparib (BMN 673)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: talazoparib
CAS Number: 1373431-65-2
Current Sponsor code: BMN 673
Other descripti
Sponsors
BioMarin Pharmaceutical Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival (PFS), Duration of response (DOR) for objective responders, and Gynecologic Cancer InterGroup (GCIG) CA125 response in patients with ovarian cancer;Timepoint(s) of evaluation of this end point: Anticipated in about 24-30 months following first patient enrolled | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine a potential association between HRD score and objective tumor response to talazoparib (BMN 673) treatment.;Secondary Objective: Secondary objectives include safety, PK, and preliminary talazoparib (BMN 673) efficacy.;Primary end point(s): Objective response rate (ORR) according to revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in patients with breast cancer and ovarian cancer.;Timepoint(s) of evaluation of this end point: Anticipated in about 24-30 months following first patient enrolled | — |
Countries
Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Korea, Republic of, Malaysia, Netherlands, Singapore, Spain, Taiwan
Contacts
Public ContactClinical Trials Information
BioMarin Pharmaceutical Inc.
Outcome results
None listed