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Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Liposomal irinotecan

    Drug

    50mg/m2 IV on days 1 and 15

  • TAS102

    Drug

    35mg/m2 PO BID on days 1-5 and 15-19

  • Bevacizumab

    Drug

    5mg/kg IV on days 1 and 15

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Participants with Metastatic or Unresectable Colorectal CancerExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS is defined as the time from D1 of treatment with the study combination until the criteria for disease progression is met as defined by RECIST 1.1 criteria or death as a result of any cause.

Time frame
up to 2 years

Secondary outcomes

1

Objective Response Rate (ORR)

ORR will include confirmed complete response (CR) + confirmed partial response (PR) per RECIST 1.1 divided by the number of patients receiving at least one dose of proposed combination.

Time frame
up to 2 years
2

Number of Participants Experiencing Grade 3 and 4 Toxicities

Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)

Time frame
up to 30 days post-treatment (approximately 6 months on study)
3

Summary of Grade 3 and 4 Toxicities by Count of participants

Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (version 5.0) (CTCAE v5.0)

Time frame
up to 30 days post-treatment (approximately 6 months on study)
4

Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens

PFS will be compared between those subjects who were treated in the last 4 months with an irinotecan containing regimen versus those who were not

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Ipsen

Collaborator

Source ClinicalTrials.gov
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