Clincosm LogoSign in Get a demo

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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT00688415
Collaborator
(none)
33
Enrollment
2
Locations
23.8
Actual Duration (Months)
16.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Nov 7, 2008
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Safety and identification of dose-limiting toxicities [Study duration]

  2. Pharmacokinetics [First dose of investigational drug]

Secondary Outcome Measures

  1. Pharmacodynamics [Study duration]

  2. Identification of the MTD [First cycle of investigational drug]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Scottsdale Arizona United States
2 Scottsdale Healthcare Scottsdale Arizona United States

Sponsors and Collaborators

  • Celgene

Investigators

  • Study Director: Amar Patel, MD, Celgene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT00688415
Other Study ID Numbers:
  • VRXP-A101
First Posted:
Jun 3, 2008
Last Update Posted:
Sep 25, 2019
Last Verified:
Sep 1, 2019
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Sep 25, 2019