The Efficacy and Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.

Sponsor

Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05732129

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Preclinical data support the investigation of PARP inhibitors in other neoplasms exhibiting homologous recombination deficiency (HRD) as monotherapy as well as in combination with chemotherapy. However，in colorectal cancer (CRC), the role of HRD alterations is mostly unknown. This study aims to explore the the Efficacy and Safety of Fluzoparib combined with Irinotecan in the Second-line treatment of HRD alterations metastatic colorectal cancer.

Condition or Disease	Intervention/Treatment	Phase
Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer	Drug: Fluzoparib Drug: Irinotecan	Phase 2

Detailed Description

Study protocol for an open-label, single-arm, phase II study of combination of Fluzoparib and rinotecan as the second-line treatment for patients with HRD alterations metastatic colorectal cancer (mCRC). Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of Fluzoparib Combined With Fluzoparib as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer: A Single-center, Open-label, Single-arm Study .

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluzoparib plus Irinotecan Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks .	Drug: Fluzoparib 150mg,orally, bid (days 1-7) every 2 weeks Drug: Irinotecan 30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w

Arm

Intervention/Treatment

Experimental: Fluzoparib plus Irinotecan

Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks .

Drug: Fluzoparib

150mg,orally, bid (days 1-7) every 2 weeks

Drug: Irinotecan

30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w

Outcome Measures

Primary Outcome Measures

Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response [assessed up to 1 year]
using RECIST v 1.1.

Secondary Outcome Measures

Progression-Free Survival of Metastatic Colorectal Cancer，includ time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first [assessed up to 1 year]
Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Overall survival of Metastatic Colorectal Cancer, include time from randomization to death from any cause [assessed up to 2 year]
Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
The Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer. [assessed up to 2 year]
time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-75 years；
Histological or cytological confirmed metastatic colorectal cancer;
HRD alterations（inclued BRCA1/2、ATM、CDK12、PALB2、Check2、RAD51C、RAD51D etc.）；
Intolerability toxicity occurs 8 weeks within first-line therapy;
ECOG PS 0-1;
Adequate hepatic, renal, heart, and hematologic functions;
Negative serum pregnancy test at screening for women of childbearing potential;
Informed consent was signed before the study began.

Exclusion Criteria:

Prior treatment with PARPi drugs；
Symptomatic brain or meningeal metastases；
Patients have received local radiotherapy within 1 month prior to treatment;
Patients who had active bleeding or coagulopathy before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
Expected survival <3 months;
Received other investigational drugs within 4 weeks prior to treatment;
Patients who had active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response;
Allergy to the study drug or any of its excipients;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Colorectal Surgery Fudan University Shanghai Caner Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ye Xu, Professor, Chief of Department of Colorectal Surgery, Fudan University

ClinicalTrials.gov Identifier:

NCT05732129

Other Study ID Numbers:

2207257-12

First Posted:

Feb 16, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ye Xu, Professor, Chief of Department of Colorectal Surgery, Fudan University

Fluzoparib Plus Irinotecan

Homologous Recombination Deficiency (HRD) Alterations

Additional relevant MeSH terms:

Colorectal Neoplasms

Irinotecan

Study Results

No Results Posted as of Feb 24, 2023