Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies

This study has been completed.

First Received on July 24, 2007. Last Updated on May 27, 2010 History of Changes

Sponsor:	Pfizer
Collaborator:	Serenex, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00506805

Purpose

Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.

Condition	Intervention	Phase
Cancer	Drug: SNX-5422	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1, Open-label, Dose-escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

adverse events and other safety assessments [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	June 2007
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Arm	Drug: SNX-5422 dose escalated, tablets every other day; undetermined duration until disease progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

>18 years old
histologically confirmed solid tumor malignancy
refractory to available therapy or for which no therapy is available
adequate organ function

Exclusion Criteria:

CNS malignancy
significant GI disease
at risk for prolonged QT interval

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506805

Locations

United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Pfizer

Serenex, Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00506805 History of Changes
Other Study ID Numbers:	B1311001, SNX-5422-CLN1-001
Study First Received:	July 24, 2007
Last Updated:	May 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

solid tumor malignancy; Hsp90

Additional relevant MeSH terms:

Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012