Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas

Lymphoma Clinical Trial

Official title:

Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647764
• Other study ID #: B1311003
• Secondary ID: PO7318
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2008
• Last updated: May 15, 2012
• Start date: March 2008
• Est. completion date: September 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 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: 32
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Solid tumors or lymphoid malignancies refractory to standard therapy

• measurable disease

• recovery to Grade < 1 toxicity due to prior adverse event or chemotherapy

• no chemotherapy within 4 weeks of entering study

• Age > 18 years

• Karnofsy >= 60%

• Life expectancy > 3 months

• normal or adequate organ and marrow function

Exclusion Criteria:

• receiving other investigational agents

• brain metastases

• uncontrolled medical illness

• HIV+ receiving combination antiretroviral therapy

• significant GI disease

Study Design

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoid Malignancy (Lymphoma and CLL)
• Lymphoma
• Neoplasms
• Solid Tumor Malignancy

Intervention

Drug:
• SNX-5422 Mesylate Hsp90 inhibitor
dose escalated, tablets twice a week; undetermined duration until disease progression

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Esanex Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD, safety and toxicity		continuous	Yes
Secondary	pharmacokinetic profile of SNX-5422		first cycle	No
Secondary	tumor response measured by X-rays or scans		after every 2 cycles	No

External Links

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