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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688415
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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
Advanced Solid Tumors Lymphoma Drug: VTX-2337 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : November 7, 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine



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.


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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688415


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Amar Patel, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00688415    
Other Study ID Numbers: VRXP-A101
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases