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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688415
• Other study ID #: VRXP-A101
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2008
• Est. completion date: November 2010

Study information

• Verified date: September 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma

Intervention

Drug:
• VTX-2337
Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona
United States	Scottsdale Healthcare	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and identification of dose-limiting toxicities		Study duration
Primary	Pharmacokinetics		First dose of investigational drug
Secondary	Pharmacodynamics		Study duration
Secondary	Identification of the MTD		First cycle of investigational drug