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Advanced/Metastatic Colorectal CancerPhase 2FINDNCT05480280

mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer

A Phase 2 study testing Dalpiciclib, Oxaliplatin injection and Calcium folinate in people with Advanced/Metastatic Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced/Metastatic Colorectal Cancer
What is being tested?
Dalpiciclib, Oxaliplatin injection and Calcium folinate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
20 Jul 2022to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Xiaojian Wu, Ph.D contact

+86-13760608396

wuxjian@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Xiaojian Wu, Ph.D., +86-13760608396, wuxjian@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Dalpiciclib, Oxaliplatin injection, Calcium folinate, 5-fluorouracil
Keywords
Colorectal cancer, Dalpiciclib, Efficacy and safety
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalpiciclibDrug

    Also called SHR6390

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

  • Oxaliplatin injectionDrug

    Also called L-OHP

    85mg/m², ivdrip, D1

  • Calcium folinateDrug

    Also called Leucovorin

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

  • 5-fluorouracilDrug

    Also called Fluorouracil; 5-FU

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

Study groups in NCT05480280
Study groupRoleWhat they receive
mFOLFOX6 + dalpiciclibExperimentalDalpiciclib is orally administered at 125mg qd for 21 days and discontinue for 7 days. mFOLFOX6 will be administered every 2 weeks.
Receives: Drug: Dalpiciclib; Drug: Oxaliplatin injection; Drug: Calcium folinate; Drug: 5-fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 year

  2. 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.

    Measured: 1 year

Secondary outcomes (2)

  1. Progression-free Survival (PFS)

    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.

    Measured: 1 year

  2. Overall Survival (OS)

    OS was defined as the date from enrollment to the date of death or the last follow-up.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start20 Jul 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an prospective, single-center, single-arm, Simon's two-stage design, phase IIa study.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05480280
Sponsor's protocol ID
2022-057
Acronym
FIND
Status last verified
Feb 2023
First submitted
28 Jul 2022
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dalpiciclib, Oxaliplatin injection and Calcium folinate in people with Advanced/Metastatic Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaojian Wu, Ph.D (+86-13760608396, wuxjian@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Adverse Events) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05480280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

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