Know Cancer

forgot password

Phase 1
18 Years
Open (Enrolling)

Thank you

Trial Information

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab

Outcome Description:

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.

Outcome Time Frame:

Day 1 - Day 28

Safety Issue:


Principal Investigator

Clinical Trial Management

Investigator Role:

Study Director

Investigator Affiliation:

Regeneron Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

August 2014

Related Keywords:

  • Cancer



Albany, New York  12208
Austin, Texas  78705
Flint, Michigan  48532