mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer

NCT05480280 | Unknown Phase 2

• 1 other identifier: 2022-057
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced/Metastatic Colorectal Cancer

Keywords

Colorectal cancer, Dalpiciclib, Efficacy and safety

Outcome Measures

Primary Outcomes (2)

• Safety (Adverse Events)

  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)

  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 Outcomes (2)

• Progression-free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

Study Arms (1)

mFOLFOX6 + dalpiciclib

EXPERIMENTAL

Dalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days. mFOLFOX6 will be administered every 2 weeks.

Drug: Dalpiciclib; Drug: Oxaliplatin injection; Drug: Calcium folinate; Drug: 5-fluorouracil

Interventions

Dalpiciclib DRUG

Dalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days.

Also known as: SHR6390

mFOLFOX6 + dalpiciclib

Oxaliplatin injection DRUG

85mg/m², ivdrip, D1

Also known as: L-OHP

mFOLFOX6 + dalpiciclib

Calcium folinate DRUG

400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1

Also known as: Leucovorin

mFOLFOX6 + dalpiciclib

5-fluorouracil DRUG

400mg/m², iv, D1; and 2400mg/m², civ, 46-48h

Also known as: Fluorouracil; 5-FU

mFOLFOX6 + dalpiciclib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

dalpiciclib; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiaojian Wu, Ph.D

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojian Wu, Ph.D

CONTACT

+86-13760608396; wuxjian@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is an prospective, single-center, single-arm, Simon's two-stage design, phase IIa study.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 29, 2022
• Study Start: July 20, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)