No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
SCRI Development Innovations, LLC · Other
Who this trial is looking for
This trial is looking for adults with metastatic colorectal cancer who have already received one type of treatment. Participants will take a combination of Fruquintinib and FOLFIRI to see how well it works and how safe it is.
Are You a Good Fit for This Trial?
Rules you outUncontrolled brain metastasesUncontrolled gastrointestinal diseaseUncontrolled hypertension
You may be able to join if
I am at least 18 years old.
I have been diagnosed with metastatic colorectal cancer.
I have at least one measurable cancer lesion.
I have completed at least 2 cycles of first-line therapy that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent.
I have not had more than one prior systemic treatment for metastatic colorectal cancer.
I have a performance status score of 0 to 2.
You may not be able to join if
I am currently receiving other anticancer treatments.
I have had major surgery in the last 4 weeks.
I received specific treatments for my cancer that are not allowed.
I have uncontrolled or symptomatic brain metastases.
I have uncontrolled or symptomatic gastrointestinal disease.
I have uncontrolled hypertension.
I am pregnant, nursing, or planning to become pregnant.
I have significant ECG abnormalities.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
* Evaluate the safety of the combin…
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
* Evaluate the safety of the combination of fruquintinib + FOLFIRI
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Key Inclusion Criteria:
* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
* Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
* Participants must have receive…
Key Inclusion Criteria:
* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
* Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
* Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
Key Exclusion Criteria:
* Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
* Major surgery within 4 weeks of the first planned dose of study treatment
* More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
* Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
* Uncontrolled, symptomatic brain metastases
* Uncontrolled, symptomatic gastrointestinal disease
* Participants with uncontrolled hypertension
* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
* Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
* Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
* Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening
Contacts
Sarah Cannon Sarah Cannon Development Innovations, LLC
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
