Trial record 1 of 1 for:    NCT01727869
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Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer

This study is currently recruiting participants.
Verified September 2013 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01727869
First received: November 2, 2012
Last updated: September 24, 2013
Last verified: September 2013

November 2, 2012
September 24, 2013
October 2012
August 2014   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01727869 on ClinicalTrials.gov Archive Site
Recommended Phase 2 Dose (RP2D) [ Time Frame: Day 1 to Day 28 ] [ Designated as safety issue: Yes ]
Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab
Same as current
Not Provided
Not Provided
 
Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Drug: REGN1400
  • Drug: Erlotinib
  • Drug: Cetuximab
  • Experimental: Cohort 1
    Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
    Interventions:
    • Drug: REGN1400
    • Drug: Erlotinib
    • Drug: Cetuximab
  • Experimental: Cohort 2
    Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
    Interventions:
    • Drug: REGN1400
    • Drug: Erlotinib
    • Drug: Cetuximab
  • Experimental: Cohort 3
    Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
    Interventions:
    • Drug: REGN1400
    • Drug: Erlotinib
    • Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
59
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com
United States
 
NCT01727869
R1400-ST-1113
No
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
September 2013

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