BrUOG 390: Neoadjuvant Treatment With Talazoparib

NCT04598321

Last updated date
Study Location
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Contact
401-863-3000

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
BRCA1 Mutation, BRCA2 Mutation, Ovarian Cancer, Fallopian Tube Cancer, High Grade Serous Carcinoma
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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BRCA1 Mutation, BRCA2 Mutation, Ovarian Cancer, Fallopian Tube Cancer, High Grade Serous CarcinomaBrUOG 390: Neoadjuvant Treatment With Talazoparib
NCT04598321
  1. Providence, Rhode Island
  2. Providence, Rhode Island
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • High Grade Serous Carcinoma
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
 (submitted: October 16, 2020)
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:

  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.

Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Gender Eligibility Description:Female sex at birth.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BrUOG401-863-3000[email protected]
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
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Don Dizon, Brown University
Study Sponsor  ICMJE Don Dizon
Collaborators  ICMJE
  • Pfizer
  • Brown University
  • Lifespan
Investigators  ICMJE
Principal Investigator:Don S Dizon, MDBrown University
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