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

This study has been completed.
Information provided by:
VentiRx Pharmaceuticals Inc. Identifier:
First received: May 29, 2008
Last updated: December 21, 2010
Last verified: December 2010
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 Intervention Phase
Advanced Solid Tumors Lymphoma Drug: VTX-2337 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:

Further study details as provided by VentiRx Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety and identification of dose-limiting toxicities [ Time Frame: Study duration ]
  • Pharmacokinetics [ Time Frame: First dose of investigational drug ]

Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: Study duration ]
  • Identification of the MTD [ Time Frame: First cycle of investigational drug ]

Enrollment: 33
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: VTX-2337
    Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00688415

United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Sponsors and Collaborators
VentiRx Pharmaceuticals Inc.
  More Information

Responsible Party: Kristi Manjarrez/Sr Director of Clinical Affairs, VentiRx Pharmaceuticals Identifier: NCT00688415     History of Changes
Other Study ID Numbers: VRXP-A101
Study First Received: May 29, 2008
Last Updated: December 21, 2010

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on September 21, 2017