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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety and identification of dose-limiting toxicities

Outcome Time Frame:

Study duration

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

VRXP-A101

NCT ID:

NCT00688415

Start Date:

November 2008

Completion Date:

November 2010

Related Keywords:

  • Advanced Solid Tumors
  • Lymphoma
  • Lymphoma

Name

Location

Mayo ClinicScottsdale, Arizona  
Scottsdale HealthcareScottsdale, Arizona  85251