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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01727869
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN1400 — DRUG
  • Erlotinib — DRUG
  • Cetuximab — DRUG

Study Details

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.

Key Dates

First listed
Nov 16, 2012
Start date
Oct 31, 2012
Status verified
Apr 2015
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
  • Experimental: Cohort 2
    Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
  • Experimental: Cohort 3
    Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab

Primary Outcome Measure

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

Locations (6)

FacilityCityStateZIPSite coordinators
-Santa MonicaCalifornia--
-AtlantaGeorgia--
-DetroitMichigan--
-BuffaloNew York--
-New YorkNew York--
-San AntonioTexas--

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