Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT ID: NCT02316834
Last Updated: 2022-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
4 participants
INTERVENTIONAL
2015-06-02
2022-01-14
Brief Summary
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Detailed Description
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I. To explore basal levels and effects of talazoparib (BMN 673) on DNA copy number, loss of heterozygosity and mutation, and level of ribonucleic acid (RNA) and protein expression (together described as "molecular results") in homologous recombination-related pathways before and after treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
I. To correlate molecular results to clinical endpoints including response and survival.
II. To correlate molecular results to pathologic endpoints including tumor volume and apoptosis.
III. To compare DNA copy number and level of RNA and protein expression in homologous recombination-related pathways in tissue from patients treated with BMN 673 to those untreated with BMN 673 in the preoperative period.
IV. To determine the toxicity of daily BMN 673 given preoperatively, with a focus on postoperative wound healing.
V. To determine feasibility of daily BMN 673 given preoperatively.
OUTLINE:
Patients receive talazoparib orally (PO) once daily (QD) for up to 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMN 673
Laboratory Biomarker Analysis
Correlative studies
BMN 673
BMN673 given at a dose of 1 mg orally once daily.
Participants begin taking BMN 673 tablets by mouth every day, starting on the day of scheduled laparoscopy. Participants take the study drug for at least 7 days before scheduled tumor reduction surgery.
Interventions
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Laboratory Biomarker Analysis
Correlative studies
BMN 673
BMN673 given at a dose of 1 mg orally once daily.
Participants begin taking BMN 673 tablets by mouth every day, starting on the day of scheduled laparoscopy. Participants take the study drug for at least 7 days before scheduled tumor reduction surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medically able to undergo primary cytoreductive surgery, at least 7 days and up to 28 days after starting study drug, as determined by treating physician
* No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
* Patients must be able to swallow and tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of BMN 673 (e.g. uncontrolled nausea, vomiting, or diarrhea; malabsorption syndrome; ulcerative disease)
* Absolute neutrophil count \>= 1,500/mcL (measured within 28 days prior to entry/ randomization)
* Hemoglobin \>= 9 gm/dL (measured within 28 days prior to entry/ randomization)
* Platelets \>= 100,000/mcL (measured within 28 days prior to entry/ randomization)
* Total bilirubin =\< 1.5 X upper limit of normal (ULN) (measured within 28 days prior to entry/ randomization)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal unless the liver is involved with tumor, in that case, ALT/AST must be =\< 5 x upper limit of normal (measured within 28 days prior to entry/ randomization)
* Creatinine clearance \>= 50 mL/min (assessed by Cockcroft Gault estimation) (measured within 28 days prior to entry/ randomization)
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry until 30 days after the last dose of study medication; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments
* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation; male partners should be instructed to use contraception during the study period
* Women must not breast-feed while taking the study medications
* Patients must be able to understand and willing to sign an informed consent
Exclusion Criteria
* Receipt of any other investigational agents or any additional anti-cancer agents
* Significant symptom burden from presumed diagnosis including large volume ascites, pain requiring narcotic medication, or shortness of breath on exertion
* 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
* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease \[bilateral, diffuse, parenchymal lung disease\], uncontrolled chronic renal diseases \[glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis\]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure \>= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required
* As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Shannon Westin
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States
Countries
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References
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Sun C, Fang Y, Labrie M, Li X, Mills GB. Systems approach to rational combination therapy: PARP inhibitors. Biochem Soc Trans. 2020 Jun 30;48(3):1101-1108. doi: 10.1042/BST20191092.
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2014-02608
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0474
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0474
Identifier Type: -
Identifier Source: org_study_id
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