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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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2024-05-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Preoperative Niraparib
Single arm. Following the initial assessment and endometrial biopsy the participants will receive niraparib for 28 days. After the treatment period the patients will be surgically staged. All participants will receive the standard of care.
Niraparib oral capsule
Low dose oral niraparib capsules (2 x 100 mg) once a day for 28 days
Interventions
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Niraparib oral capsule
Low dose oral niraparib capsules (2 x 100 mg) once a day for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological and staging criteria:
Patients must have histologically diagnosed
1. Grade 3 endometrioid, serous or clear cell endometrial carcinoma, carcinosarcoma, undifferentiated carcinoma in Stage I-III according to International Federation of Gynecology and Obstetrics (FIGO) classification.
2. Grade 2 endometrioid carcinoma with abnormal TP53 by immunohistochemistry.
3. Surgical criteria: patients with operable disease are eligible
4. Patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[hCG\]) within 7 days prior to receiving the first dose of niraparib.
5. Patients must be postmenopausal, free from menses for \>1 year, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 3 months after the last dose of niraparib.
6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Patients must have adequate organ function, defined as follows:
1. Absolute neutrophil count ≥ 1,500/µL
2. Platelets ≥ 100,000/µL
3. Hemoglobin ≥ 10 g/dL
4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation
5. Total bilirubin ≤ 1.5 x ULN
6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.0 x ULN
8. Patients must be able to take oral medications
Exclusion Criteria
1. Grade 1 endometrioid carcinoma OR
2. Grade 2 endometrioid carcinoma with wild type TP53 OR
3. Grade 2 endometrioid carcinoma with an unknown TP53 status
2. Patient did not consent for the study biopsy and one of the following:
* the original endometrial biopsy tissue block could not be assessed by the study site pathologist
* the original endometrial biopsy tissue block does not contain sufficient tumor tissue
3. Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment and for 3 months after the last dose of study treatment;
4. Patient has a known hypersensitivity to the components of niraparib or its excipients;
5. Patient is simultaneously enrolled in any clinical trial of niraparib or any other investigational therapy;
6. Patient has had any known ≥Grade 3 anemia, neutropenia or thrombocytopenia due to any prior medication that persisted \>4 weeks;
7. Patient has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myelocytic anemia (AML);
8. Patient has undergone major surgery (per investigator judgment) within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery;
9. Patient has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment, including:
1. Patient received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment;
2. Patient received colony-stimulating factors (eg, granulocyte colony stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.
10. Another concurrent invasive neoplastic disease (including ovarian), diagnosis of cancer in the last 5 years (except for non-melanoma skin cancer), patient previously had cancer (\> 5 years) but she is not considered cured or still treated.
11. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
\- Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
12. Patient is immunocompromised (patients with splenectomy are allowed).
13. Patient has known, active hepatic disease (ie, hepatitis B or C).
14. Patient has a corrected QT interval (QTc) prolongation \> 470 milliseconds at screening; - If a patient has a prolonged QTc interval and the prolongation is deemed to be due to a pacemaker upon investigator evaluation (ie, the patient otherwise has no cardiac abnormalities), then the patient may be eligible to participate in the study following approval of a cardiology specialist.
18 Years
FEMALE
No
Sponsors
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Sir Mortimer B. Davis - Jewish General Hospital
OTHER
Responsible Party
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Shannon Salvador
Principal Investigator
Principal Investigators
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Shannon Salvador, MD MSc
Role: PRINCIPAL_INVESTIGATOR
McGill University, Jewish General Hospital
Walter Gotlieb, MD PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University, Jewish General Hospital
References
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de Jonge MM, Auguste A, van Wijk LM, Schouten PC, Meijers M, Ter Haar NT, Smit VTHBM, Nout RA, Glaire MA, Church DN, Vrieling H, Job B, Boursin Y, de Kroon CD, Rouleau E, Leary A, Vreeswijk MPG, Bosse T. Frequent Homologous Recombination Deficiency in High-grade Endometrial Carcinomas. Clin Cancer Res. 2019 Feb 1;25(3):1087-1097. doi: 10.1158/1078-0432.CCR-18-1443. Epub 2018 Nov 9.
Urick ME, Bell DW. Clinical actionability of molecular targets in endometrial cancer. Nat Rev Cancer. 2019 Sep;19(9):510-521. doi: 10.1038/s41568-019-0177-x. Epub 2019 Aug 6.
Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.
Romero I, Rubio MJ, Medina M, Matias-Guiu X, Santacana M, Schoenenberger JA, Guerra EM, Cortes A, Minig L, Coronado P, Cueva JF, Gomez L, Malfettone A, Sampayo M, Llombart-Cussac A, Poveda A. An olaparib window-of-opportunity trial in patients with early-stage endometrial carcinoma: POLEN study. Gynecol Oncol. 2020 Dec;159(3):721-731. doi: 10.1016/j.ygyno.2020.09.013. Epub 2020 Sep 26.
Other Identifiers
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301014
Identifier Type: -
Identifier Source: org_study_id