Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
Phase 1
Completed
- Conditions
- Advanced Solid TumorsLymphoma
- Registration Number
- NCT00688415
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and identification of dose-limiting toxicities Study duration Pharmacokinetics First dose of investigational drug
- Secondary Outcome Measures
Name Time Method Identification of the MTD First cycle of investigational drug Pharmacodynamics Study duration
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States