Status:

COMPLETED

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

Lead Sponsor:

Celgene

Conditions:

Advanced Solid Tumors

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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 invest...

Eligibility Criteria

Inclusion

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

  • 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

Key Trial Info

Start Date :

November 7 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT00688415

Start Date

November 7 2008

End Date

November 1 2010

Last Update

September 25 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Mayo Clinic

Scottsdale, Arizona, United States

2

Scottsdale Healthcare

Scottsdale, Arizona, United States