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OpenTrials
Completed

NCT Number: NCT00688415

Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer

This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.

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Key information

Conditions

Advanced Solid Tumors Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Other specific eligibility criteria may apply. Examination by the investigator is necessary to fully determine eligibility.

Inclusion criteria

  • Ability and willingness to provide written informed consent
  • Histologically or cytologically confirmed solid tumors or lymphoma
  • Locally advanced or metastatic disease
  • Life expectancy of at least 16 weeks
  • ECOG performance status of 0 or 1
  • Acceptable physical exam and laboratory tests at study entry
  • Willingness to use medically acceptable contraception
  • A negative serum pregnancy test for women with reproductive potential

Exclusion criteria

  • Anticancer therapy within 2 weeks
  • Treatment with an investigational agent within 4 weeks
  • Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
  • Known brain metastases unless stable for at least 28 days
  • Active autoimmune disease
  • Insulin-dependent diabetes mellitus
  • Clinically significant cardiac disease within 6 months
  • Significant infection or fever within 1 week
  • Pregnant or breast-feeding females
  • Other conditions or circumstances that could interfere with the study

Treatment and study plan

VTX-2337

Drug

Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.

Primary outcomes

  1. Safety and identification of dose-limiting toxicities

    Time frame: Study duration

  2. Pharmacokinetics

    Time frame: First dose of investigational drug

Secondary outcomes

  1. Pharmacodynamics

    Time frame: Study duration

  2. Identification of the MTD

    Time frame: First cycle of investigational drug

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2008
Registry last updated
Sep 25, 2019

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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