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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01727869
First received: November 2, 2012
Last updated: April 2, 2015
Last verified: April 2015
  Purpose
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.

Condition Intervention Phase
Cancer Drug: REGN1400 Drug: Erlotinib Drug: Cetuximab Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 56
Study Start Date: October 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Drug: REGN1400 Drug: Erlotinib Drug: Cetuximab
Experimental: Cohort 2
Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Drug: REGN1400 Drug: Erlotinib Drug: Cetuximab
Experimental: Cohort 3
Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Drug: REGN1400 Drug: Erlotinib Drug: Cetuximab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727869

Locations
United States, California
Santa Monica, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Michigan
Detroit, Michigan, United States
United States, New York
Buffalo, New York, United States
New York, New York, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01727869     History of Changes
Other Study ID Numbers: R1400-ST-1113
Study First Received: November 2, 2012
Last Updated: April 2, 2015

Additional relevant MeSH terms:
Cetuximab
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 27, 2017