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

This study is currently recruiting participants.
Verified May 2013 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01727869
First received: November 2, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab


Estimated Enrollment: 59
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727869

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

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

No publications provided

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: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cetuximab
Erlotinib
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013