Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
This study has been completed.
Sponsor:
Esanex Inc.
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
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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
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 May 23, 2013