Phase I VTX-2337 (TLR8 Agonist ) trial at Mayo in Arizona

[Rich66]

Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer
This study is currently recruiting participants.
Verified by VentiRx Pharmaceuticals Inc., November 2008
Sponsored by: VentiRx Pharmaceuticals Inc.
Information provided by: VentiRx Pharmaceuticals Inc. ClinicalTrials.gov Identifier: NCT00688415

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 I

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Non-Randomized, Open Label, Single Group Assignment

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

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 ]

Estimated Enrollment:
21
Study Start Date:
November 2008
Estimated Primary Completion Date:
June 2009 (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

Contacts
Contact: Amber Mann, BS, MBA (910) 558-2956

Locations
United States, Arizona Mayo Clinic Recruiting Scottsdale, Arizona, United States Contact: Deborah Gallagher, RN 480-301-4038 Gallagher.Deborah@mayo.edu Principal Investigator: Dr. Northfelt, M.D. Scottsdale Healthcare Recruiting Scottsdale, Arizona, United States Contact: Joyce Ingold, Rn, MSN, OCN 480-323-1339 jingold@shc.org Principal Investigator: Dr. Ramanathan, MD Sponsors and Collaborators
VentiRx Pharmaceuticals Inc.


More Information
Responsible Party:
VentiRx Pharmaceuticals ( Kristi Manjarrez/Sr Director of Clinical Affairs )
Study ID Numbers:
VRXP-A101
First Received:
May 29, 2008
Last Updated:
November 10, 2008
ClinicalTrials.gov Identifier:
NCT00688415 [history]
Health Authority:
United States: Food and Drug Administration

Study placed in the following topic categories: Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma



Additional relevant MeSH terms: Neoplasms
Neoplasms by Histologic Type
Immune System Diseases



ClinicalTrials.gov processed this record on December 19, 2008