Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06237205
Brief Summary:
Investigational Products: Niraparib Period: 3 years after IRB/EC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing
Detailed Description:
Objectives:
1. Primary Objective
\- Antitumor activity defined as objective response at ≥ 8 weeks or stable disease (SD) at ≥ 16 weeks from the time of enrollment.
2. Secondary Objectives
* Overall Survival (OS)
* Progression-Free Survival (PFS)
* Objective Response Rate (ORR) by RECIST v1.1
* Duration of response (DOR)
* Quality of life (QOL) assessed by EORTC-QLQ-C30
* Adverse Event (AEs)
* Exploratory biomarker analyses
Study:
NCT06237205
Study Brief:
Protocol Section:
NCT06237205