Colorectal CancerPhase 2NCT03727763
Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT)
A Phase 2 study testing Vemurafenib and Cetuximab in people with Colorectal Cancer, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Vemurafenib and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have histologically or cytologically confirmed advanced or recurrent CRC;
- Patients with BRAV V600E mutation/KRAS WT based on the NGS or ARMS-PCR detection of tumor tissue;
- Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
- Patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy;
- Patients without a history of receiving vemurafenib or cetuximab;
- Patients with age of 18-75yr;
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- Patients with a performance status of 0,1or 2 on the Eastern Cooperative Oncology Group.；
- Patients with Life expectancy of more than 12 weeks;
- Patients must have the ability to understand and sign the written informed consent voluntarily;
- Female of childbearing potential who are negative in a pregnancy test within 14 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.
Who cannot join
- Patients with KRAS/NRAS mutation;
- Patients with major surgery or severe trauma within 4 weeks before the first medication;
- Patients with hypersensitivity to the components in the study protocol;；
- Patients who are ready to give birth or are pregnant.。
- Patients with brain metastases 。
- Bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows：
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- Neutrophil count<1,500/mm3；
- Platelet count <80,000/mm3；
- Total bilirubin >1.5-times the upper limit of normal；
- ALT/AST>2.5-times the upper limit of normal for patients without liver metastases; (5.0-times the upper limit of normal for patients without liver metastases)
- Creatinine >1.5-times the upper limit of normal；
- Patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;；
- Patients without legal capacity or limited civil capacity;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200433
Zhan Wang, Prof., +8613916229609, profoundamir@139.com
About this study
Official title: Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT): A Single-arm Study
This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.
- Conditions
- Colorectal Cancer
- Being tested
- Vemurafenib, Cetuximab
- Keywords
- FLOFIRI, vemurafenib, cetuximab, BRAF V600E mutation, Advanced Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemurafenibDrug
Also called PLX4032, RG7204
960mg po bid
CetuximabDrug
Also called ERBITUX
500mg/m2 iv gtt (14 days per course)
| Study group | Role | What they receive |
|---|---|---|
| FIVC group | Experimental | Irinotecan 180mg/m2 iv gtt (14 days per course) leucovorin 400mg/m2 iv gtt (14 days per course) 5-fluorouracil 400mg/m2 iv (14 days per course) 5-fluorouracil 2400 mg/m2 46h (14 days per course) vemurafenib 960mg po bid cetuximab 500mg/m2 iv gtt (14 days per course) Receives: Drug: Vemurafenib; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response.
Measured: up to 55 months
Secondary outcomes (4)
Disease Control Rate (DCR)
Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), and DCR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response, partial response and stable disease
Measured: up to 55 months
Progression-free survival
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks
Measured: Time from treatment beginning until the date of first documented progression, assessed up to 55 months
Overall survival
From date of treatment beginning until the date of death from any cause, through study completion, an average of 6 weeks
Measured: Time from treatment beginning until date of death from any cause, assessed up to 55 months
adverse events
Incidence of Treatment-related adverse Events
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start8 Oct 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhan Wang, Shanghai Changzheng Hospital
- Investigators
- Zhan Wang, Prof, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727763
- Sponsor's protocol ID
- IMPROVEMENT
- Status last verified
- Aug 2021
- First submitted
- 31 Oct 2018
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Z, Qin BD, Ye CY, Wang MM, Yuan LY, Dai WP, Sun L, Liu K, Qin WX, Jiao XD, Li XN, Zang YS. Cetuximab and vemurafenib plus FOLFIRI (5-fluorouracil/leucovorin/irinotecan) for BRAF V600E-mutated advanced colorectal cancer (IMPROVEMENT): An open-label, single-arm, phase II trial. Eur J Cancer. 2022 Mar;163:152-162. doi: 10.1016/j.ejca.2021.12.028. Epub 2022 Jan 21.
PubMed 35074651
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT): A Single-arm Study
- ClinicalTrials.gov ID
- NCT03727763
- Acronym / sponsor ID
- IMPROVEMENT
- Conditions
- Colorectal Cancer
- Keywords
- FLOFIRI, vemurafenib, cetuximab, BRAF V600E mutation, Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Nov 2018 (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.
This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIVC group | Experimental | Drug: Vemurafenib, Drug: CetuximabIrinotecan 180mg/m2 iv gtt (14 days per course) leucovorin 400mg/m2 iv gtt (14 days per course) 5-fluorouracil 400mg/m2 iv (14 days per course) 5-fluorouracil 2400 mg/m2 46h (14 days per course) vemurafenib 960mg po bid cetuximab 500mg/m2 iv gtt (14 days per course) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients have histologically or cytologically confirmed advanced or recurrent CRC;
- Patients with BRAV V600E mutation/KRAS WT based on the NGS or ARMS-PCR detection of tumor tissue;
- Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
- Patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy;
- Patients without a history of receiving vemurafenib or cetuximab;
Key exclusion criteria (13 listed)
- Patients with KRAS/NRAS mutation;
- Patients with major surgery or severe trauma within 4 weeks before the first medication;
- Patients with hypersensitivity to the components in the study protocol;；
- Patients who are ready to give birth or are pregnant.。
- Patients with brain metastases 。
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 |
|---|---|---|
| VemurafenibAlso: PLX4032, RG7204960mg po bid | Drug | FIVC group |
| CetuximabAlso: ERBITUX500mg/m2 iv gtt (14 days per course) | Drug | FIVC group |
Primary outcome
Objective Response Rate(ORR)
Time frame: up to 55 months
Evaluation of tumor burden based on RECIST criteria every 3 cycles(each cycle is 14 days), ORR is the proportion of patients with reduction in tumor burden of a predefined amount, including complete response and partial response.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 55 months
Progression-free survival
Time frame: Time from treatment beginning until the date of first documented progression, assessed up to 55 months
Overall survival
Time frame: Time from treatment beginning until date of death from any cause, assessed up to 55 months
adverse events
Time frame: Through study completion, an average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 35074651Wang Z, Qin BD, Ye CY, Wang MM, Yuan LY, Dai WP, Sun L, Liu K, Qin WX, Jiao XD, Li XN, Zang YS. Cetuximab and vemurafenib plus FOLFIRI (5-fluorouracil/leucovorin/irinotecan) for BRAF V600E-mutated advanced colorectal cancer (IMPROVEMENT): An open-label, single-arm, phase II trial. Eur J Cancer. 2022 Mar;163:152-162. doi: 10.1016/j.ejca.2021.12.028. Epub 2022 Jan 21.
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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.
Zhan Wang, Prof principal investigator
Shanghai Changzheng Hospital
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 Vemurafenib and Cetuximab in people with Colorectal Cancer, run by Shanghai Changzheng 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 10 inclusion and 13 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 19 Aug 2021. 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 Yuan-Sheng Zang, Prof (+8613816584620, doctorzangys@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: up to 55 months). 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 NCT03727763, which also lists 1 linked publication.
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 19 Aug 2021.