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

This study has been completed.
Sponsor:
Information provided by:
VentiRx Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00688415
First received: May 29, 2008
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

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: 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:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by VentiRx Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety and identification of dose-limiting toxicities [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: First dose of investigational drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: Study duration ] [ Designated as safety issue: No ]
  • Identification of the MTD [ Time Frame: First cycle of investigational drug ] [ Designated as safety issue: Yes ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688415

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

No publications provided

Responsible Party: Kristi Manjarrez/Sr Director of Clinical Affairs, VentiRx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00688415     History of Changes
Other Study ID Numbers: VRXP-A101
Study First Received: May 29, 2008
Last Updated: December 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013