Spots Global Cancer Trial Database for Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

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Trial Identification

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

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

Study ID: NCT03644342

Conditions

Metastatic Carcinoma of the Cervix

Interventions

Nirapaib

Study Description

Brief 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.

Detailed Description: