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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; VentiRx Pharmaceuticals Inc.

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