Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
Primary Purpose
Advanced Solid Tumors, Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VTX-2337
Sponsored by
About this trial
This is an interventional other trial for Advanced Solid Tumors
Eligibility 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
Sites / Locations
- Mayo Clinic
- Scottsdale Healthcare
Outcomes
Primary Outcome Measures
Safety and identification of dose-limiting toxicities
Pharmacokinetics
Secondary Outcome Measures
Pharmacodynamics
Identification of the MTD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688415
Brief Title
Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2008 (Actual)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Lymphoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VTX-2337
Intervention Description
Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.
Primary Outcome Measure Information:
Title
Safety and identification of dose-limiting toxicities
Time Frame
Study duration
Title
Pharmacokinetics
Time Frame
First dose of investigational drug
Secondary Outcome Measure Information:
Title
Pharmacodynamics
Time Frame
Study duration
Title
Identification of the MTD
Time Frame
First cycle of investigational drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar Patel, MD
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
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