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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: REGN1400; Drug: Erlotinib; Drug: Cetuximab

• Registration Number: NCT01727869
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Erlotinib	Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 1	REGN1400	Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 1	Cetuximab	Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 3	REGN1400	Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 2	REGN1400	Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 2	Cetuximab	Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 2	Erlotinib	Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 3	Erlotinib	Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
Cohort 3	Cetuximab	Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab	Day 1 - Day 28	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

Name	Time	Method
Recommended Phase 2 Dose (RP2D)	Day 1 to Day 28	Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab