Liposomal Irinotecan with TAS102 and Bevacizumab for Cancer
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer
Recruiting
Phase 2Interventional Study
Metastatic Colorectal Cancer
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
50 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for adults with advanced colorectal cancer that hasn't responded to previous treatments. Participants will receive a combination of three medications to see if it helps their condition.
Are You a Good Fit for This Trial?
Must not be takingStrong CYP3A4 inducers/inhibitors
You may be able to join if
I am at least 18 years old.
I have advanced colorectal cancer that cannot be surgically removed.
I have had previous treatment with certain cancer medications.
My cancer is mismatch repair proficient.
You may not be able to join if
I have an uncontrolled medical condition that prevents me from completing treatment.
My cancer has BRAF V600 mutations.
I have had mismatch repair deficient or microsatellite instability high cancers.
I have received TAS102 before.
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 a few quick questions to see if you may meet the eligibility requirements.
This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients must be ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.
* Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
* The cancer must be mismatch r…
Inclusion Criteria:
* Patients must be ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.
* Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
* The cancer must be mismatch repair proficient.
* Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy.
Exclusion Criteria:
* Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.
* Patients whose cancers possess BRAF V600 mutations are excluded.
* Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.
* Patients must not have mismatch repair deficient or microsatellite instability high cancers.
* Patients must not have received prior TAS102.
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