BrUOG 390: Neoadjuvant Treatment With Talazoparib
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04598321 |
Recruitment Status :
Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
BRCA1 Mutation BRCA2 Mutation Ovarian Cancer Fallopian Tube Cancer High Grade Serous Carcinoma | Drug: Talazoparib Oral Capsule | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | BrUOG 390: Neoadjuvant Treatment With Talazoparib for Women With Newly Diagnosed, Advanced Ovarian Cancer Associated With a Mutation in BRCA1 or BRCA2 (mBRCA) |
Estimated Study Start Date : | January 2021 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | January 2027 |

Arm | Intervention/treatment |
---|---|
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.
|
Drug: Talazoparib Oral Capsule
An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.
Other Name: Talzenna |
- Determine the preliminary effectiveness of Talazorparib [ Time Frame: First 9 weeks of treatment ]Define the proportion of volunteers completing the planned 9 weeks of treatment without disease progression.
- Feasibility of the trial design. [ Time Frame: First 2 years of study. ]Define whether 30 volunteers can successfully be enrolled within 2 years within participating institutions.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female sex at birth. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Institutional confirmation of Müllerian epithelial adenocarcinoma
- Histologic epithelial cell types: high grade serous carcinoma, high grade endometrioid carcinoma, or a combination of these.
- Documented mutation in BRCA1 or BRCA2 by genetic or commercial somatic testing. Reports will require submission at the time of enrollment.
- 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.
- Age ≥ 18
- Female sex at birth
-
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)
- Serum Creatine<1.5 ULN
-
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
- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.
- 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.
- The volunteer must provide study-specific informed consent prior to study entry.
Exclusion Criteria:
- Suspected non-gynecologic malignancy, evidence by tumor markers and/or histologic evaluation.
- 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.
- 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.
- 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.
- 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.
-
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
- Volunteers who are not candidates for major abdominal surgery due to known medical comorbidities.
- Volunteers with any condition that in the judgment of the investigator would jeopardize safety or volunteer compliance with the protocol.
- Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy).
- 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.
-
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598321
Contact: BrUOG | 401-863-3000 | BrUOG@Brown.edu |
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
Contact: BrUOG 401-863-3000 BrUOG@Brown.edu | |
Principal Investigator: Don S Dizon, MD | |
Women & Infants Hospital | |
Providence, Rhode Island, United States, 02903 | |
Contact: BrUOG 401-863-3000 BrUOG@Brown.edu | |
Principal Investigator: Cara Mathews, MD |
Principal Investigator: | Don S Dizon, MD | Brown University |
Responsible Party: | Don Dizon, Principal Investigator, Brown University |
ClinicalTrials.gov Identifier: | NCT04598321 |
Other Study ID Numbers: |
BrUOG 390 |
First Posted: | October 22, 2020 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Cystadenocarcinoma, Serous Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases Cystadenocarcinoma Adenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Talazoparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |