Viewing Study NCT05694715



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Last Modification Date: 2024-10-26 @ 2:49 PM
Study NCT ID: NCT05694715
Status: RECRUITING
Last Update Posted: 2023-11-13
First Post: 2023-01-12

Brief Title: Combination Therapy in Cancers With Mutations in DNA Repair Genes
Sponsor: University of California San Francisco
Organization: University of California San Francisco

Study Overview

Official Title: Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this phase 1 clinical trials is to determine whether niraparib a Poly ADP-ribose polymerase inhibitor PARPi can be safely combined with irinotecan with manageable toxicity and reasonable efficacy Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wider subset of solid tumors that may have defective homologous recombination HR or DNA repair gene mutations BReast CAncer gene BRCA partner and localizer of BRCA2 PALB2 and various other DNA repair germline mutations predispose carriers to cancers of the breast ovaries pancreas prostate and melanoma A number of preclinical studies have demonstrated that PARP inhibitors can work as chemopotentiators There is significant interest in this combination and the recommended phase II dose will be used in the upcoming NCI ComboMatch trial
Detailed Description: This is an open label non-randomized phase Ib dose finding study of niraparib and irinotecan combination therapy For this study individuals with metastatic solid tumor malignancies and BRCA12 ataxia telangiectasia mutated gene ATM or PALB2 mutations will be enrolled with specific tumors of interest including gastrointestinal cancers eg colon pancreas gastric cholangiocarcinoma ovarian cancer and breast cancer

PRIMARY OBJECTIVES

I To assess safety and tolerability of niraparib and irinotecan combination therapy in patients with metastatic solid tumor malignancies and BRCA12 ATM or PALB2 mutations

II To determine the MTD and recommended phase II dose of niraparib with irinotecan combination therapy

SECONDARY OBJECTIVES

I To determine the preliminary efficacy of niraparib and irinotecan combination therapy in patients with metastatic solid tumor malignancies and BRCA12 ATM or PALB2 mutations

OVERVIEW

Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable Participants may continue treatment until disease progression unacceptable toxicity withdrawal of consent start of new anti-cancer therapy or death Participants will be followed for 30 days after study drug discontinuation for safety and every 12 weeks - 2 weeks for up to 2 years after start of therapy until disease progression or death from any cause whichever occurs first

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-2023-00373 REGISTRY NCI Clinical Trials Reporting Program CTRP None