Colorectal CancerPhase 2DOFEMCRCNCT05025631
A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）
A Phase 2 study testing Fruquintinib in people with Colorectal Cancer, run by Zhen-Yu Ding at 1 site in China.
Trial summary
A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fruquintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2020to 30 Oct 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study on Dose Optimization of Fruquintinib in Elderly Metastatic Colorectal Cancer Patients Refractory to Standard Treatment
A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.
Read the detailed description
This is a prospective, multi-center, single arm, phase II study. In this study, the low-dose initial dose incremental optimization scheme was used in the first cycle in patients ≥65 years old who need to receive fruquintinib. The aim is to observe the safety, tolerability and efficacy of fruquintinib in elderly patients with mCRC refractory to standard treatment. The correlation between the efficacy, toxicity and geriatric evaluation of fruquintinib will also be analysed.
- Conditions
- Colorectal Cancer
- Being tested
- Fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival is determined from the date of treatment to PD or death from any cause
Measured: about a year
Secondary outcomes (5)
Safety and tolerability
Version 5.0 and AEs leading to dose interruption or discontinuation.
Measured: about a year
ORR
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: about a year
DCR
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: about a year
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Measured: about a year
Correlation between geriatric assessment and efficacy and safety
Statistical results obtained by analyzing the patient's geriatric assessment against efficacy and safety
Measured: about a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start6 Nov 2020
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhen-Yu Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025631
- Sponsor's protocol ID
- HMPL-013-FLAG-C110
- Acronym
- DOFEMCRC
- Status last verified
- Apr 2023
- First submitted
- 25 Aug 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on Dose Optimization of Fruquintinib in Elderly Metastatic Colorectal Cancer Patients Refractory to Standard Treatment
- ClinicalTrials.gov ID
- NCT05025631
- Acronym / sponsor ID
- DOFEMCRC / HMPL-013-FLAG-C110
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Zhen-Yu DingUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.
Detailed description
This is a prospective, multi-center, single arm, phase II study. In this study, the low-dose initial dose incremental optimization scheme was used in the first cycle in patients ≥65 years old who need to receive fruquintinib. The aim is to observe the safety, tolerability and efficacy of fruquintinib in elderly patients with mCRC refractory to standard treatment. The correlation between the efficacy, toxicity and geriatric evaluation of fruquintinib will also be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib dose-optimization | Experimental | Drug: FruquintinibFruquintinib 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 65 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruquintinibFruquintinib 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. | Drug | Fruquintinib dose-optimization |
Primary outcome
PFS
Time frame: about a year
Progression-free survival is determined from the date of treatment to PD or death from any cause
5 secondary outcomes
Safety and tolerability
Time frame: about a year
ORR
Time frame: about a year
DCR
Time frame: about a year
OS
Time frame: about a year
Correlation between geriatric assessment and efficacy and safety
Time frame: about a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib in people with Colorectal Cancer, run by Zhen-Yu Ding 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 10 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: finished, as of the sponsor's last update on 28 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: about a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2023.