Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies

This study is currently recruiting participants.

Verified by Pfizer, January 2009

Sponsors and Collaborators:	Pfizer Serenex, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00595686

Purpose

Hsp90 is a chemical in the body that is involved in the 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
Hematologic Neoplasms Hematologic Malignancy	Drug: SNX-5422	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 1, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies

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:

disease response specific to the hematological malignancy [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	69
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental	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
Karnofsky performance status > 60
confirmed hematological malignancy
refractory to available therapy or for which no therapy is available
adequate hepatic, renal and hematological function

Exclusion Criteria:

CNS malignancy
at risk for prolonged QT interval
significant GI/liver disease
other serious concurrent illness or medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595686

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Georgia
Pfizer Investigational Site	Recruiting
Augusta, Georgia, United States, 30912
United States, North Carolina
Pfizer Investigational Site	Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Pfizer Investigational Site	Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Pfizer Investigational Site	Recruiting
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Pfizer

Serenex, Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1311002, SNX-5422-CLN1-002
Study First Received:	January 7, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00595686
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Hematologic Malignancies; Hsp90; Hematologic Malignancy

Study placed in the following topic categories:

Hematologic Neoplasms
Hematologic Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009