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Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma

NCT03213626 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-08-27

Study results available
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Summary

This is an open-label, single arm, phase II trial. Safety will be monitored on an ongoing basis. Laboratory testing (chemistry, hematology tests) will be performed every 2 weeks for the first 8 weeks followed by assessments every 4 weeks. Other safety evaluations including EKGs, urinalysis, coagulation and thyroid function studies will be performed at regular intervals.

Adverse event seriousness, severity grade, and relationship to study treatment will be assessed by the investigator. Severity grade will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Tumors will be assessed by contrast enhanced CT or MRI every 8 weeks. Pre-treatment tissue will be obtained via CT-guided FNA biopsy or collected during resection. However, archival tissue will also be requested, when available and if adequate for testing. Post-treatment tissue will be obtained on Day 15 (i.e., Week 3/Day 1) via CT-guided FNA biopsy. All tumor tissue from eligible patients will be utilized for the correlative studies which are outlined in this trial.

Each subject's course will consist of three periods:

* A Pre-Treatment Period in which subjects are consented and undergo screening assessments to be qualified for the study;
* A Treatment Period in which subjects receive study treatment and undergo study assessments. Patients who meet the eligibility criteria will be treated with cabozantinib orally at 40 mg daily and erlotinib orally at 100 mg daily without breaks;
* A Post-Treatment Period in which subjects no longer receive study treatment but undergo follow-up study assessments and contacts.

Conditions

  • Pancreatic Adenocarcinoma Metastatic

Interventions

DRUG

Cabozantinib 40 MG

To be taken orally once daily

DRUG

Erlotinib 100Mg Tab

To be taken orally once daily

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • Patrick Joseph Loehrer Sr.

    lead OTHER

Principal Investigators

  • Bert H. O'Neil, MD · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2019-04-15
Completion
2019-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03213626 on ClinicalTrials.gov