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

This study has been completed.
Sponsor:
Collaborator:
Serenex, Inc.
Information provided by:
Esanex Inc.
ClinicalTrials.gov Identifier:
NCT00595686
First received: January 7, 2008
Last updated: May 15, 2012
Last verified: May 2012
  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
Drug: SNX-5422
Phase 1

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 Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Esanex Inc.:

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 ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Esanex Inc.
Serenex, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00595686     History of Changes
Other Study ID Numbers: B1311002, SNX-5422-CLN1-002
Study First Received: January 7, 2008
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Esanex Inc.:
Hematologic Malignancies Hsp90 Hematologic Malignancy

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on August 19, 2014