Study of talazoparib (BMN 673), a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
- Conditions
- Advanced or recurrent solid tumors for which there is no accepted standard treatment or for which standard treatment has failed. Patients may also be eligible if they are unable or decline to undergo standard therapy because it has limited antitumor efficacy or has significant toxicidty.MedDRA version: 19.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023062-40-GB
- Lead Sponsor
- Medivation, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
• Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed. Patients may also be eligible if they are unable or decline to undergo standard therapy because it has limited antitumor efficacy or has significant toxicity.
• Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
• 18 years of age or older.
• Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST,
v1.1) or increased CA-125 (ovarian cancer) or prostate-specific antigen (PSA;
prostate cancer), and/or CA 19-9 (pancreatic cancer).
• Eastern Cooperative Oncology Group (ECOG) performance status = 1.
• Have adequate organ function as defined below:
o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 X upper limit of normal (ULN); if liver function abnormalities are due to hepatic metastasis, then AST and ALT may be = 5 X ULN;
o Total serum bilirubin = 1.5 X ULN;
o Hemoglobin = 9.0 g/dL with last transfusion at least 28 days before Cycle 1, Day 1;
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 research-related procedures.
• Sexually active patients must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 30 days after the last dose of BMN 673.
• Females of childbearing potential must have a negative serum pregnancy test at
screening and be willing to have additional serum pregnancy tests during the study.
Females considered not of childbearing potential include those who have been in
menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or who have had 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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
• Has not recovered (recovery is defined as National Cancer Institute (NCI) Common
Terminology Criteria for Adverse Events [CTCAE v4.03] grade = 1) from the acute
toxicities of previous therapy, except treatment-related alopecia or laboratory
abnormalities otherwise meeting the inclusion requirements stated in the inclusion
criterion.
• Part 2 Expansion: Prior treatment with a PARP inhibitor.
• Has history of central nervous system (CNS) metastasis.
• Any antitumor systemic cytotoxic therapies within 28 days before Cycle 1, Day 1
(6 weeks for nitrosoureas or mitomycin-C), treatment with immune modulators
(including, but not limited to, corticosteroids, cyclosporine and tacrolimus; locally
active treatments such as Beconase are allowed) within 28 days before Cycle 1,
Day 1, or radiotherapy within 28 days before Cycle 1, Day 1.
• Prior high-dose chemotherapy with bone marrow or stem cell transplant
• Is known to have human immunodeficiency virus (HIV) or has active hepatitis C
virus (HCV), or active hepatitis B virus (HBV).
• Has had major surgery within 28 days before Cycle 1, Day 1.
• Has active peptic ulcer disease.
• Active gastrointestinal tract disease with malabsorption syndrome.
• Requirement for IV alimentation.
• Prior surgical procedures affecting absorption.
• Uncontrolled inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Myocardial infarction within 6 months before starting therapy, symptomatic
congestive heart failure (New York Heart Association > class II), unstable angina, or
unstable cardiac arrhythmia requiring medication
• Breastfeeding at screening or planning to become pregnant (self or partner) at any
time during study participation.
• Use of any investigational product or investigational medical device within 28 days
before Cycle 1, Day 1.
• Concurrent disease or condition that would interfere with study participation or
safety, such as:
o Active, clinically significant infection requiring the use of parenteral antimicrobial
agents, or grade > 2 by NCI CTCAE (v4.03) within 14 days before
Cycle 1, Day 1;
o Clinically significant bleeding diathesis or coagulopathy, including known
platelet function disorders;
o Non-healing wound, ulcer, or bone fracture.
o Bone marrow disorder including myelodysplasia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method