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

Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727869
• Other study ID #: R1400-ST-1113
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2012
• Last updated: April 2, 2015
• Start date: October 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• REGN1400

• Erlotinib

• Cetuximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Recommended Phase 2 Dose (RP2D)	Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab	Day 1 to Day 28	Yes