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Old 12-19-2008, 01:59 PM   #1
Rich66
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Phase I VTX-2337 (TLR8 Agonist ) trial at Mayo in Arizona

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
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Old 12-19-2008, 02:01 PM   #2
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VentiRx Pharmaceuticals Commences Phase I Clinical Trial of VTX-2337, a Novel TLR8 Agonist for the Treatment of Oncology

(posted on 04/12/2008)

First Selective TLR8 Agonist to Advance to Clinical Trials

SAN DIEGO, Dec. 4 - VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 (TLR8) agonists for the treatment of cancer, respiratory and autoimmune diseases, announced today that it has initiated a Phase I clinical trial of VTX-2337, a selective TLR8 agonist for the treatment of cancer. The multi-center clinical trial is being conducted at the Mayo Clinic Arizona and TGen Drug Development Services (TD2) both in Scottsdale, Arizona.

“We are delighted to advance the first molecule from our Toll-Like Receptor 8 platform, VTX-2337, into the clinic,” said Michael Kamdar, Executive Vice President and Chief Business Officer at VentiRx. “This represents a significant milestone for VentiRx and our TLR efforts as we have rapidly advanced into a clinical development company with a novel molecule that may have broad application in the treatment of cancer.”

VTX-2337 is a small molecule TLR8 agonist that is expected to be used in combination with standard of care for the treatment of patients with cancer. Preclinical evaluation of VTX-2337 suggests that it may play a key role in augmenting the innate arm of the immune system and provide a valuable addition to various treatment regimens in oncology. The first clinical trial will investigate the safety and pharmacology of multiple doses of VTX-2337 in patients with late stage cancer.

“VTX-2337 is the first selective TLR8 compound to reach the clinic and we are hopeful that modulation of the innate immune response will provide a benefit to patients in a number of oncology indications,” said Dr. Robert Hershberg, Executive Vice President and Chief Medical Officer at VentiRx.

About VentiRx Pharmaceuticals
VentiRx Pharmaceuticals, Inc. is a biopharmaceutical company committed to the development and commercialization of novel medicines for the treatment of cancer, respiratory and autoimmune diseases. The Company's initial focus is on developing small molecule TLR-based product candidates for oncology and allergy. VentiRx is a privately held organization headquartered in San Diego with operations in Seattle. For additional information, please visit www.ventirx.com.
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Old 02-07-2010, 02:05 AM   #3
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Phase I VTX 2337 TLR8 Agonist trial at Mayo in Arizona

I would find it helpful if users had an area to post clinical trials they come across. For instance, I just found a trial of Gemzar and Alimta at the Mayo clinic for gallbladder cancer.
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