Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer

April 2, 2015 updated by: Regeneron Pharmaceuticals
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Michigan
      • Detroit, Michigan, United States
    • New York
      • Buffalo, New York, United States
      • New York, New York, United States
    • Texas
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria include, but are not limited to, the following:

  1. Confirmed diagnosis of certain unresectable or metastatic cancers
  2. Adequate Eastern Cooperative Oncology Group (ECOG) performance status
  3. Adequate hepatic, renal and bone marrow function
  4. Resolution of toxicity from prior therapy to grade less than/ = to 1

Exclusion Criteria include, but are not limited to, the following:

  1. Active brain metastases
  2. Thromboembolic events < 6 months prior to study
  3. Patients with a recent history (within 5 years) of another malignancy.
  4. Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400
  5. Patients who are pregnant or nursing
  6. Prior treatment with ErbB3 inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Drug: Cetuximab
Drug: Erlotinib
Drug: REGN1400
Experimental: Cohort 2
Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Drug: Cetuximab
Drug: Erlotinib
Drug: REGN1400
Experimental: Cohort 3
Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Drug: Cetuximab
Drug: Erlotinib
Drug: REGN1400

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
Time Frame: Day 1 - Day 28
Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.
Day 1 - Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 Dose (RP2D)
Time Frame: Day 1 to Day 28
Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab
Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1400-ST-1113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe