ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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401-863-3000
1. Volunteers must have clinical and radiographic evidence of newly detected FIGO stage II, III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, deemed by a gynecologic oncologist as not amenable to an R0 resection at presentation.
2. Institutional confirmation of Müllerian epithelial adenocarcinoma
3. Histologic epithelial cell types: high grade serous carcinoma, high grade endometrioid carcinoma, or a combination of these.
4. Documented mutation in BRCA1 or BRCA2 by genetic or commercial somatic testing. Reports will require submission at the time of enrollment.
5. Measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.
6. Age ≥ 18
7. Female sex at birth
8. Adequate hematologic function determined within 28 days of consent as follows:
- ANC greater than or equal to 1,500/mcl. NOTE: ANC cannot have been induced by granulocyte colony stimulating factors.
- Platelets greater than or equal to 100,000/mcl
- Hemoglobin greater than 10 mg/dl (transfusions are permitted to achieve baseline hemoglobin level. Note: may not have transfusion within 14 days prior to obtaining baseline screening labs)
9. Serum Creatine<1.5 ULN
10. Adequate hepatic function within 14 days prior to registration defined as follows:
- Bilirubin ≤ 1.5 x ULN
- ALT and AST ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
11. Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.
12. Ability to swallow and retain oral medication. Adequate gastrointestinal absorption with no use of parenteral nutrition within two weeks of trial enrollment and no evidence of bowel obstruction.
13. The volunteer must provide study-specific informed consent prior to study entry.
1. Suspected non-gynecologic malignancy, evidence by tumor markers and/or histologic
evaluation.
2. Prior history of other invasive malignancies, with the exception of nonmelanoma skin
cancer and other specific malignancies are excluded if there is any evidence of other
malignancy being present within the last three years (2 years for breast cancer).
Volunteers are also excluded if their previous cancer treatment contraindicates this
protocol therapy.
3. Prior chemotherapy for any abdominal or pelvic tumor within the last three years is
excluded. Volunteers may have received prior adjuvant chemotherapy and radiotherapy
for localized breast cancer, provided that it was completed more than 2 years prior to
registration, the volunteer remains free of recurrent or metastatic disease and
hormonal therapy has been discontinued.
4. Prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity
within the last three years are excluded. Prior radiation for localized cancer of the
head and neck or skin is permitted, provided that it was completed more than three
years prior to registration, and the volunteer remains free of recurrent or metastatic
disease.
5. Synchronous primary endometrial cancer, or a past history of primary endometrial
cancer, unless all of the following conditions are met: Stage not greater than I-A,
grade 1 or 2, no more than superficial myometrial invasion, without vascular or
lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or
other FIGO grade 3 lesions.
6. Severe, active co-morbidity defined as follows:
- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal or antiviral treatment
- Known brain or central nervous system metastases or history of uncontrolled
seizures
- Clinically significant cardiac disease including unstable angina, acute
myocardial infarction within 6 months from enrollment, New York Heart Association
Class III or IV congestive heart failure, and serious arrhythmia requiring
medication (this does not include asymptomatic atrial fibrillation with
controlled ventricular rate).
- Partial or complete gastrointestinal obstruction
7. Volunteers who are not candidates for major abdominal surgery due to known medical
comorbidities.
8. Volunteers with any condition that in the judgment of the investigator would
jeopardize safety or volunteer compliance with the protocol.
9. Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy,
immunotherapy, hormonal therapy, investigational therapy).
10. Receipt of an investigational study drug for any indication within 30 days or 5
half-lives (whichever is longer) prior to Day 1 of protocol therapy.
11. No prior exposure to a PARP inhibitor.
- The criteria for premenopausal women are as follows:
- Any female who has experienced menarche and who has not undergone surgical
sterilization (hysterectomy and/or bilateral oophorectomy) or who is not
postmenopausal. Menopause is defined clinically as 12-month amenorrhea in a woman
over 45 in the absence of other biological or physiological causes.
- Volunteers who are pregnant or nursing. Volunteers must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry, for the duration of study participation, and for at least 7 months
after completing therapy.
- WOCBP must have a screening negative serum or urine pregnancy test within 14 days
of registration. A second pregnancy test must be done within 24 hours prior to
the start of the first cycle of study treatment.
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Descriptive Information | |||||||
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Brief Title ICMJE | BrUOG 390: Neoadjuvant Treatment With Talazoparib | ||||||
Official Title ICMJE | BrUOG 390: Neoadjuvant Treatment With Talazoparib for Women With Newly Diagnosed, Advanced Ovarian Cancer Associated With a Mutation in BRCA1 or BRCA2 (mBRCA) | ||||||
Brief Summary | Ovarian cancer is the most fatal gynecologic cancer; in the US alone an estimated 22,000 women will be diagnosed in 2019, with over 13,000 dying of the disease. Approximately half of epithelial ovarian cancers (EOC) exhibit defective DNA repair through alterations in the homologous recombination (HR) pathway, with 14% accounted for by germline mutations in BRCA genes (mBRCA); this goes up to about one in five (20%) women when one includes tumor-associated (somatic) mBRCA.The approach to women with mBRCA-associated ovarian cancer has heralded precision treatment in our field with the availability of PARP inhibitors. Now indicated as treatment for women with documented mBRCA (genomic or somatic), it also has shown significant benefits for women with recurrent EOC who respond to platinum-based therapy when administered as maintenance treatment. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE | Drug: Talazoparib Oral Capsule
An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations. Other Name: Talzenna | ||||||
Study Arms ICMJE | Experimental: Planned Therapy
Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Intervention: Drug: Talazoparib Oral Capsule | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE | 30 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | January 2027 | ||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04598321 | ||||||
Other Study ID Numbers ICMJE | BrUOG 390 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Don Dizon, Brown University | ||||||
Study Sponsor ICMJE | Don Dizon | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Brown University | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |