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

This study is currently recruiting participants.

Verified by VentiRx Pharmaceuticals Inc., June 2009

First Received: May 29, 2008 Last Updated: June 12, 2009 History of Changes

Sponsor:	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

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

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 ]

Estimated Enrollment:	21
Study Start Date:	November 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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: Aliou Ousmanou, Pharm D

(919) 456-4205

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

No publications provided

Responsible Party:	VentiRx Pharmaceuticals ( Kristi Manjarrez/Sr Director of Clinical Affairs )
Study ID Numbers:	VRXP-A101
Study First Received:	May 29, 2008
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00688415 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 20, 2009