Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer
Both
Cancer
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:
Interventional
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:
Yes
Principal Investigator
Clinical Trial Management
Investigator Role:
Study Director
Investigator Affiliation:
Regeneron Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
R1400-ST-1113
NCT ID:
NCT01727869
Start Date:
October 2012
Completion Date:
August 2014
Related Keywords:
- Cancer
Name | Location |
|---|---|
| Albany, New York 12208 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 |
