mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer (FIND)

February 25, 2023 updated by: Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University

mFOLFOX6 Combined With Dalpiciclib(SHR6390) in Patients With Metastatic Colorectal Cancer (FIND): A Single-arm, Phase IIa Study.

This is an prospective, single-center, single-arm, Simon's two-stage design, phase IIa study for advanced/metastatic colorectal cancer (CRC) who had failed or were intolerant to standard treatment. This study aims to evaluate the safety and efficacy of mFOLFOX6 combined with dalpiciclib (SHR6390) in the treatment of advanced/metastatic colorectal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Primary study end point:

    To evaluate the safety and objective response rate (ORR) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment.

  2. Secondary study end Point:

To evaluate the progression-free survival (PFS) and overall survival (OS) of mFOLFOX6 combined with dalpiciclib (SHR6390) in patients with advanced/metastatic colorectal cancer who had failed or were intolerant to standard treatment.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects voluntarily sign informed consent
  • Age: from 18 to 70 years old
  • Definite histological evidence of colorectal adenocarcinoma
  • ECOG 0-1
  • Advanced or metastatic colorectal cancer (AJCC/UICC stage IV) is confirmed by enhanced CT of the chest, abdomen and pelvis, with evaluable lesions
  • Tumor progression or intolerable toxicity after previous standard treatment; Tumor progression during adjuvant therapy or within 6 months after completion of adjuvant therapy was considered as first-line treatment (Standard treatment must include all of the following drugs: fluorouracil, irinotecan, and oxaliplatin; With or without anti-VEGF monoclonal antibody (bevacizumab); Anti-EGFR treatment(cetuximab or panitumumab) in left colorectal RAS (KRAS/NRAS) wild-type subjects)
  • The bone marrow, liver and kidney function satisfies the following conditions within 7 days before treatment (including day 7):

Hemoglobin ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥75×109/L; aspartate aminotransferase (AST) ≤ 2 upper limit of normal (ULN), glutaminate alanine transaminase (ALT) ≤ 3 ULN, total bilirubin ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN

  • Peripheral neurological lesions recover (≤ grade 1) before enrollment
  • Subjects should not participate in other clinical trials during the study period
  • Willing and able to comply with research procedures and follow-up plan

Exclusion Criteria:

  • Complicated with obstruction, active bleeding or perforation and requiring emergency surgery or stent placement
  • Existing or coexisting other active malignancies
  • Previously CDK inhibitors treatment
  • Major surgery or severe trauma such as laparotomy, thoracotomy or laparoscopic organ removal within the previous 4 weeks
  • Active coronary artery disease, severe/unstable angina or newly diagnosed angina or myocardial infarction in the past 12 months
  • Thrombotic or embolic events occurred within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism or deep vein thrombosis
  • New York Heart Association (NYHA) Class II or higher Congestive heart failure
  • Presence of clinically symptomatic third space effusion (eg, massive pleural or ascites) that cannot be controlled by drainage or other methods
  • Human immunodeficiency virus (HIV) infection or diseases associated with acquired immunodeficiency syndrome (AIDS)
  • Active inflammatory bowel disease or other colorectal disease leading to chronic diarrhea
  • Presence of CTCAE grade 2 or higher toxicity (other than anemia, alopecia and skin pigmentation) that has not recover due to any previous treatment
  • Suspected allergies to any of the relevant drugs used in the study
  • Pregnant or lactating
  • Women of childbearing age (<2 years after last menstrual period) or men of childbearing potential not using or refusing to use effective non-hormonal contraception
  • Any unstable medical condition that affects patient safety and study compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mFOLFOX6 + dalpiciclib
Dalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days. mFOLFOX6 will be administered every 2 weeks.
Drug: Dalpiciclib
Dalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days.
Other Names:
  • SHR6390
Drug: Oxaliplatin injection
85mg/m², ivdrip, D1
Other Names:
  • L-OHP
Drug: Calcium folinate
400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
Other Names:
  • Leucovorin
Drug: 5-fluorouracil
400mg/m², iv, D1; and 2400mg/m², civ, 46-48h
Other Names:
  • Fluorouracil; 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Adverse Events)
Time Frame: 1 year
The number of subjects who had adverse events and the type of adverse events were recorded according to CTCAE V.5.0. Safety failure was defined as any grade 3-5 treat-related adverse event (AE) (CTCAE 5.0) within 90 days from the date of the last regimen (whichever was reached later).
1 year
Objective Response Rate (ORR)
Time Frame: 1 year
ORR was defined as the proportion of all subjects who received the study treatment and whose best overall response (BOR) was a complete response (CR) or a partial response (PR) according to RECIST version 1.1.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: 1 year
PFS was defined as the date from enrollment to the first recorded of tumor progression (assessed by RECIST version 1.1) or the date of death from any cause, whichever came first.
1 year
Overall Survival (OS)
Time Frame: 1 year
OS was defined as the date from enrollment to the date of death or the last follow-up.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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