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Metastatic Colorectal CancerPhase 1/2NCT05522738

Safety and Efficacy of Fruquintinib+FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

A Phase 1/2 study testing Combination: Fruquintinib + FOLFIRI in people with Metastatic Colorectal Cancer, run by Chinese PLA General Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Molecular subtypes make difference on clinicopathologic features and response to chemotherapy and targeted agents as well as prognosis. RAS mutation status, which accounting for approximately 35% to 40% of colorectal cancer patients, is an important factor considered in the standard of care for colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Combination: Fruquintinib + FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
10 Aug 2022to Dec 2025
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understand the study and voluntarily sign the informed consent form;
  • Age ≥ 18 years;
  • Pathologically confirmed unresectable metastatic colorectal cancer;
  • Known RAS gene mutations;
  • failed standard first-line FOLFOX/XELOX combined with bevacizumab;
  • ECOG performance status 0-1;
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  • BMI ≥ 18;
  • Expected survival ≥ 3 months;
  • Vital organ function meets the following requirements (any blood components and cell growth factors are not allowed within 14 days before enrollment):
  • Absolute neutrophil count ≥ 1.5 × 109/L and white blood cells ≥ 4.0 × 109/L;
  • Platelets ≥ 100 x 109/L;
  • Hemoglobin ≥ 90 g/L;
  • Total bilirubin TBIL ≤ 1.5 × ULN;
  • ALT and AST ≤ 5 x ULN;
  • Urea nitrogen/urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 x ULN (and creatinine clearance (CCr) ≥ 50 mL/min);
  • Left ventricular ejection fraction (LVEF) > = 50%;
  • Fridericia corrected QT interval (QTcF) < 470 milliseconds.
  • INR ≤ 1.5 x ULN, APTT ≤ 1.5 x ULN.
  • Women of childbearing age should take effective contraceptive measures;
  • Good compliance and cooperation with follow-up.

Who cannot join

  • Unable to comply with the study protocol or study procedures;
  • Known BRAF gene mutations;
  • evidence of central nervous system metastasis, or associated with severe malignant pleural effusion and ascites;
  • Previous treatment with irinotecan;
  • previous treatment with VEGFR inhibitor
  • Concurrent use of any other investigational drug, or enrollment in a clinical trial of other investigational drug therapy within 4 weeks before enrollment;
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  • Inactivated vaccines within 4 weeks before enrollment or possibly during the study;
  • patients in the study group underwent major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;
  • Receiving blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 28 days before enrollment;
  • Alcohol or drug abuse within 4 weeks prior to enrollment;
  • Any factor affecting oral administration;
  • Concurrent any of the following: uncontrolled hypertension, coronary artery disease, arrhythmia, and heart failure;
  • Uncontrollable serious concurrent infections resulting in disability;
  • Proteinuria ≥ 2 + (1.0 g/24 h)
  • Evidence or history of bleeding tendency within 2 months before enrollment, regardless of seriousness;
  • Arterial/venous thromboembolic events, such as cerebrovascular accidents (including transient ischemic attack), within 12 months before the first treatment;
  • Acute myocardial infarction, acute coronary syndrome or CABG within 6 months prior to the first treatment;
  • Fractures or wounds that have not been healed for a long time;
  • Coagulopathy, bleeding tendency, or ongoing anticoagulant therapy;
  • Patients with other malignant tumors within 5 years before enrollment, except for skin basal cell carcinoma or squamous cell carcinoma after radical resection, or cervical carcinoma in situ;
  • Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;
  • Previous allogeneic bone marrow transplantation or organ transplantation;
  • Subjects who are allergic to the study drug or any of its excipients;
  • clinically significant electrolyte abnormalities judged by the investigator;
  • Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must have excluded active HBV infection, ie, positive HBV DNA (> 1 × 104 copies/mL or > 2000 IU/mL); known hepatitis C virus (HCV) infection and positive HCV RNA (> 1 × 103 copies/mL);
  • Unresolved toxicities above CTCAE v5.0 grade 1 due to any prior anticancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity ≤ grade 2;
  • Any other diseases, clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the investigator 's judgment, there is reason to suspect that the patient has a disease or condition that is not suitable for the use of the study drug (such as having seizures and requiring treatment), or will affect the interpretation of the study results, or put the patient at high risk;
  • Pregnant or lactating females;
  • Patients who the investigator considers inappropriate for inclusion in this study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing

    Guanghai Dai, +8666947252, daigh301@vip.sina.com

    Guanghai Dai

    Recruiting

Other trials in China

About this study

Official title: Prospective, Single-arm, Single-center Phase Ib/II Trial on the Safety and Efficacy of Fruquintinib in Combination With FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

Molecular subtypes make difference on clinicopathologic features and response to chemotherapy and targeted agents as well as prognosis. RAS mutation status, which accounting for approximately 35% to 40% of colorectal cancer patients, is an important factor considered in the standard of care for colorectal cancer. For RAS-mutated patients, no targeted driver gene drugs have been approved, and their treatment is based on the anti-VEGF/VEGFR pathway, and corresponding targeted drugs such as bevacizumab, aflibercept, and ramucirumab have also been successfully marketed for the treatment of CRC.

For RAS mutant metastatic colorectal cancer, the commonly used first-line treatment regimen is bevacizumab combined with chemotherapy, which is shown in previous studiesthat the PFS of 1st-line is about 10 months; the standard regimen of second-line treatment is FOLFIRI ± bevacizumab, which is shown in previous study that the 2nd-line PFS is about 5 months with ORR 4%. There are a lot of unmet medical needs to improve the clinical efficacy in secondline-treatment of RAS-mutant patients.

Read the detailed description

This is a prospective, single-armed, single-center phase Ib/II study to investigate the safety and efficacy of Fruquintinib combined with FOLFIRI in RAS-mutant patients who failed first-line standard therapy.

Being tested
Combination: Fruquintinib + FOLFIRI
Keywords
RAS-mutant, second-line
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Combination: Fruquintinib + FOLFIRIDrug

    Also called Elunate, HMPL-013

    Phase 1b Fruquintinib was administered in a 3 + 3 dose escalation regimen at the following doses: L1:3 mg/d, L2:4 mg/d, L3:5 mg/d.

    Fruquintinib: QD po q2w

    FOLFIRI regimen:

    Irinotecan：180 mg/m2, i.v. , d1, q2w LV：200 mg/m2, i.v., d1, q2w 5-FU：2400 mg/m2, i.v.for over 46 hours, q2w

    Phase II Fruquintinib: RP2D, QD po q2w

    FOLFIRI regimen:

    Irinotecan： 180 mg/m2, i.v. , d1, q2w LV： 200 mg/m2, i.v., d1, q2w 5-FU：2400 mg/m2, i.v.for over 46 hours, q2w

Study groups in NCT05522738
Study groupRoleWhat they receive
study groupExperimentalFruquintinib combined with FOLFIRI
Receives: Drug: Combination: Fruquintinib + FOLFIRI

What is being measured

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

  1. Objective Response Rate

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year

  2. RP2D

    RECIST v1.1

    Measured: from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year

Secondary outcomes (5)

  1. Overall Survival

    every two months follow up after EOT observation period at 30 days after the last medication

    Measured: from treatment initiation until death due to any cause, assessed up to 3 year

  2. Progress-Free Survival

    every two months follow up after EOT observation period at 30 days after the last medication

    Measured: from treatment initiation until death due to any cause, assessed up to 2 year

  3. Duration of Response

    every two months follow up after EOT observation period at 30 days after the last medication

    Measured: from treatment initiation until death due to any cause, assessed up to 2 year

  4. Safety and tolerance evaluated by incidence of AE

    Incidence and severity of AE

    Measured: from first dose to 30 days post the last dose

  5. Safety and tolerance evaluated by incidence of SAE

    Incidence and severity of SAE

    Measured: from first dose to 30 days post the last dose

Timeline

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

  1. First posted31 Aug 2022
  2. Study start10 Aug 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522738
Sponsor's protocol ID
HMPL-013-N1-CRC104
Status last verified
Jan 2024
First submitted
23 Aug 2022
Last updated
8 Jan 2024
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 1/2 study testing Combination: Fruquintinib + FOLFIRI in people with Metastatic Colorectal Cancer, run by Chinese PLA General Hospital 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 20 inclusion and 29 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 8 Jan 2024. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: From treatment initiation to progressive disease or EOT due to any cause, assessed up to 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 NCT05522738.

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 8 Jan 2024.

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