Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
1 other identifier
interventional
56
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 cancer
Started Oct 2012
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 2, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 6, 2015
April 1, 2015
2.3 years
November 2, 2012
April 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
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 Outcomes (1)
Recommended Phase 2 Dose (RP2D)
Day 1 to Day 28
Study Arms (3)
Cohort 1
EXPERIMENTALDosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 2
EXPERIMENTALDosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 3
EXPERIMENTALDosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of certain unresectable or metastatic cancers
- Adequate Eastern Cooperative Oncology Group (ECOG) performance status
- Adequate hepatic, renal and bone marrow function
- Resolution of toxicity from prior therapy to grade less than/ = to 1
You may not qualify if:
- Active brain metastases
- Thromboembolic events \< 6 months prior to study
- Patients with a recent history (within 5 years) of another malignancy.
- Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400
- Patients who are pregnant or nursing
- Prior treatment with ErbB3 inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2012
First Posted
November 16, 2012
Study Start
October 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 6, 2015
Record last verified: 2015-04