NCT03213626

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

A Phase II Trial of Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Patrick Joseph Loehrer Sr. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective The primary objective of this trial is to demonstrate a radiographic response rate of 15% or greater for the combination in a selected population. Secondary Objectives The secondary objectives of this trial are: * To estimate progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS); and * To assess safety and tolerability of this combination in the target patient population. Correlative Objectives The following tests will be performed on blood and tumor tissue samples collected during this trial to correlate with PFS and OS: * c-Met and EGFR mRNA by RT-qPCR * plasma HGF and soluble Met receptor * c-Met and EGFR phosphoprotein levels by IHC * KRAS mutation status

Conditions

• Pancreatic Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Cabozantinib 40 MG	To be taken orally once daily
DRUG	Erlotinib 100Mg Tab	To be taken orally once daily

Timeline

• Start date: 2017-10-13
• Primary completion: 2019-04-15
• Completion: 2019-11-18
• First posted: 2017-07-11
• Last updated: 2020-08-27
• Results posted: 2020-08-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study