BrUOG 390: Neoadjuvant Treatment With Talazoparib

  • STATUS
    Recruiting
  • End date
    Jan 25, 2027
  • participants needed
    30
  • sponsor
    Brown University
Updated on 25 July 2022
measurable disease
carcinoma
breast cancer
x-rays
colony stimulating factor
neuropathy
adenocarcinoma
parp inhibitor
ovarian cancer
BRCA1
BRCA2
fallopian tube
gynecologic cancer
endometrioid adenocarcinoma
ovarian epithelial carcinoma
cancer of the ovary

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.

Details
Condition BRCA1 Mutation, BRCA2 Mutation, Ovarian Cancer, Fallopian Tube Cancer, High Grade Serous Carcinoma
Treatment Talazoparib Oral Capsule
Clinical Study IdentifierNCT04598321
SponsorBrown University
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

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.14
Age ≥ 18
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
Hemoglobin greater than 10 mg/dl (NOTE: While transfusions are permitted to achieve baseline hemoglobin level, patients must not have transfusion within 14 days prior to obtaining baseline screening labs)
Platelets greater than or equal to 100,000/mcl
Creatinine Clearance > 15 mL/min. (NOTE: Please see Section 6.2.1 for dosing
requirements for patients with renal insufficiency)
Adequate hepatic function within 14 days prior to registration defined as follows
CrCl = (140- age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg
dL
Bilirubin ≤ 1.5 x ULN
ALT and AST < 2.5 x ULN
Alkaline phosphatase ≤ 2.5 x ULN
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
Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v5.0
The volunteer must provide study-specific informed consent prior to study entry
Grade 1

Exclusion Criteria

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
Suspected non-gynecologic malignancy, evidenced by tumor markers and/or histologic evaluation
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
Prior history of other invasive malignancies, with the exception of nonmelanoma skin cancer and other specific malignancies as noted in Section 4.2.4 and Section 4.2.5 are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer, see Section 4.2.4). Volunteers are also excluded if their previous cancer treatment contraindicates this protocol therapy
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 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)
Volunteers who are not candidates for major abdominal surgery due to known medical
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
comorbidities
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
Prior exposure to a PARP inhibitor
People of child-bearing potential (WOCB). This includes
Any volunteer 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
People with an intact uterus and ovaries 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
Potent P-gp inhibitors that result in ≥ 2-fold increase in the exposure of an in vivo
probe P-gp substrate, including: amiodarone, carvedilol, clarithromycin, cobicistat
dronedarone, erythromycin, glecaprevir/pibrentasvir, indinavir, itraconazole
ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir
saquinavir, sofosbuvir/velpatasvir/voxilaprevir, telaprevir, tipranavir, valspodar and
verapamil
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