NCT05025631

Brief Summary

A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

August 25, 2021

Last Update Submit

April 26, 2023

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression-free survival is determined from the date of treatment to PD or death from any cause

    about a year

Secondary Outcomes (5)

  • Safety and tolerability

    about a year

  • ORR

    about a year

  • DCR

    about a year

  • OS

    about a year

  • Correlation between geriatric assessment and efficacy and safety

    about a year

Study Arms (1)

Fruquintinib dose-optimization

EXPERIMENTAL

Fruquintinib was administered orally on 21 consecutive days in a 28-day treatment cycle. All patients were dose-optimized for the first cycle of fruquintinib - oral fruquintinib 3 mg/day in the first week; if tolerated, oral fruquintinib 4 mg/day in the second week; if still tolerated, then the dose was increased to 5 mg/day in the third week. From the second cycle, patients were given the maximum dose that they have tolerated in the first cycle.

Drug: Fruquintinib

Interventions

FruquintinibDRUG

Fruquintinib was administered for 21 consecutive days of a 28-day treatment cycle. The starting dose of fruquintinib was 3 mg/day, weekly incremental dose escalation occurred up to the maximum of 5 mg/day if no significant drug-related toxicities were observed. The highest tolerated dose from cycle 1 would be administered in cycle 2 and all subsequent cycles.

Fruquintinib dose-optimization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and older;
  • Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;
  • ECOG PS 0-1;
  • At least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment;
  • Life expectancy ≥ 3 months;
  • Cooperative in observation of adverse events and curative effect;
  • No other anti-tumor concomitant treatment (including steroid drugs);
  • Adequate organ and bone marrow functions;
  • At least one measurable lesion(s);
  • Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.

You may not qualify if:

  • Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;
  • Evidence of central nervous system metastasis;
  • One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;
  • Abuse of alcohol or drugs;
  • Less than 4 weeks from the last clinical trial;
  • Previous treatment with VEGFR inhibitors;
  • Severe uncontrolled disability with concurrent infection;
  • Proteinuria ≥ 2 + (1.0g / 24hr);
  • Uncontrollable gastrointestinal bleeding;
  • Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;
  • Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;
  • Fracture or wound that has not been cured for a long time;
  • Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;
  • Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);
  • Patients who are not suitable for the study judged by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China West Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

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

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 27, 2021

Study Start

November 6, 2020

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

CN(1)