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

Celgene

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Lymphoma

Treatments

Drug: VTX-2337

Study type

Interventional

Funder types

Industry

Identifiers

NCT00688415

VRXP-A101

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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