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OpenTrials
Completed

NCT Number: NCT01727869

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

include, but are not limited to, the following:

  • Confirmed diagnosis of certain unresectable or metastatic cancers
  • Adequate Eastern Cooperative Oncology Group (ECOG) performance status
  • Adequate hepatic, renal and bone marrow function
  • Resolution of toxicity from prior therapy to grade less than/ = to 1

Exclusion criteria

include, but are not limited to, the following:

  • Active brain metastases
  • Thromboembolic events < 6 months prior to study
  • Patients with a recent history (within 5 years) of another malignancy.
  • Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400
  • Patients who are pregnant or nursing
  • Prior treatment with ErbB3 inhibitors

Treatment and study plan

REGN1400

Drug

Erlotinib

Drug

Cetuximab

Drug

Primary outcomes

  1. 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

    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 outcomes

  1. Recommended Phase 2 Dose (RP2D)

    Time frame: Day 1 to Day 28

    Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 16, 2012
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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