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

Hematologic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595686
• Other study ID #: B1311002
• Secondary ID: SNX-5422-CLN1-00
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2008
• Last updated: May 15, 2012
• Start date: January 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2012
• Source: Esanex Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

Drug:
• SNX-5422
dose escalated; tablets every other day; undetermined duration until disease progression

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Augusta	Georgia
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Esanex Inc.	Serenex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events and other safety assessments		continuous	Yes
Secondary	disease response specific to the hematological malignancy		after every 2 cycles	No

External Links

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