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

Primary Purpose

Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Irinotecan
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer focused on measuring Fluzoparib Plus Irinotecan, Homologous Recombination Deficiency (HRD) Alterations

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Department of Colorectal Surgery Fudan University Shanghai Caner Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluzoparib plus Irinotecan

Arm Description

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 .

Outcomes

Primary Outcome Measures

Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response
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
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
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.
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

Full Information

First Posted
February 8, 2023
Last Updated
February 22, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05732129
Brief Title
The Efficacy and Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.
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 .
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer
Keywords
Fluzoparib Plus Irinotecan, Homologous Recombination Deficiency (HRD) Alterations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluzoparib plus Irinotecan
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Intervention Description
150mg,orally, bid (days 1-7) every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w
Primary Outcome Measure Information:
Title
Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response
Description
using RECIST v 1.1.
Time Frame
assessed up to 1 year
Secondary Outcome Measure Information:
Title
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
Description
Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Time Frame
assessed up to 1 year
Title
Overall survival of Metastatic Colorectal Cancer, include time from randomization to death from any cause
Description
Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Time Frame
assessed up to 2 year
Title
The Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.
Description
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
Time Frame
assessed up to 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Xu, PhD
Phone
+86-21-6417-5590
Email
xu_shirley021@163.com
Facility Information:
Facility Name
Department of Colorectal Surgery Fudan University Shanghai Caner Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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