Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
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
1 other identifier
interventional
33
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2008
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedStudy Start
First participant enrolled
November 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 25, 2019
September 1, 2019
1.7 years
May 29, 2008
September 23, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and identification of dose-limiting toxicities
Study duration
Pharmacokinetics
First dose of investigational drug
Secondary Outcomes (2)
Pharmacodynamics
Study duration
Identification of the MTD
First cycle of investigational drug
Interventions
Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (2)
Mayo Clinic
Scottsdale, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amar Patel, MD
Celgene
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
November 7, 2008
Primary Completion
August 1, 2010
Study Completion
November 1, 2010
Last Updated
September 25, 2019
Record last verified: 2019-09