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Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

Phase I/II Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

NCT03644342•Michelle S Ludwig

View on ClinicalTrials.gov

Summary

The most effective strategy for managing distantly metastatic invasive carcinomas of the cervix is not defined. Based on the success of niraparib in breast and ovarian cancer trials and the concern for toxicities and comorbidities limiting the compliance of concurrent cisplatin for cervical cancer, this study is a phase I/II study of women diagnosed with distantly metastatic (Stage IV) disease to determine the maximum tolerated dose and to evaluate the safety, tolerability and preliminary efficacy of niraparib, an orally available small molecule PARP inhibitor when administered concurrently with definitive regional radiotherapy for treatment of cervical cancer. Women enrolled in this study will receive 3-6 cycles of induction-style carboplatin and paclitaxel followed by definitive doses of pelvic radiotherapy along with the oral niraparib given at the same time.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Participant must have histologically confirmed diagnosis of invasive squamous cell or adenocarcinoma of the cervix, FIGO Stage IIIC2 or IV (see Appendix 5 of the currently approved protocol).
•2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
•3. Participant must be ≥ 18 years of age.
•4. Participant must have adequate organ function within 28 days of registration, defined as follows:
•* Absolute neutrophil count ≥ 1,500/µL
•* Platelets ≥ 100,000/µL
•* Hemoglobin ≥ 9 g/dL
•* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
•* Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
•* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
+12 more criteria

Exclusion Criteria

•1. Participant must not be simultaneously enrolled in any interventional clinical trial.
•2. Participant must not have known documented intra-uterine pregnancy.
•3. Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
•4. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. Participant that has received prior treatment with a PARP inhibitor is excluded from this study.
•5. Participant last treatment with platinum based chemotherapy was ≥12 weeks from initiation of protocol therapy.
•6. Participant must not receive any additional chemotherapy while on study.
•7. Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
•8. Participant must not have a known hypersensitivity to niraparib components or excipients.
•9. Participant must not have received colony stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior to initiating protocol therapy.
•10. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
+2 more criteria

Locations (3)

Baylor College of Medicine

Houston, Texas, United States

Baylor St. Luke's Medical Center McNair

Houston, Texas, United States

Harris Health System - Smith Clinic

Houston, Texas, United States

Key Dates

Start Date

July 15, 2019

Primary Completion Date

April 18, 2022

Completion Date

September 27, 2023

Last Updated

September 3, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Carcinoma of the Cervix

Interventions

Nirapaib

DRUG