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Clinical Trials/NCT00688415
NCT00688415CompletedPhase 1

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

Celgene2 sites in 1 country33 target enrollmentStarted: November 7, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Celgene
Enrollment
33
Locations
2
Primary Endpoint
Safety and identification of dose-limiting toxicities
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

Safety and identification of dose-limiting toxicities

Time Frame: Study duration

Pharmacokinetics

Time Frame: First dose of investigational drug

Secondary Outcomes

  • Pharmacodynamics(Study duration)
  • Identification of the MTD(First cycle of investigational drug)

Investigators

Sponsor
Celgene
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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