Safety and Pharmacology Study of SNX-5422 in Subjects With Refractory Hematological Malignancies

NCT01635712 | Completed Phase 1

• 1 other identifier: SNX-5422-CLN1-005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

Hsp90 is a chemical in the body that is involved int he promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90.

Conditions

Cancer

Keywords

Hematological Malignancy; Hsp90

Outcome Measures

Primary Outcomes (1)

• Number of patients with dose limiting toxicities

  Number of patients with dose-limiting toxicities defined as AEs or laboratory abnormalities of Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.03 ≥ Grade 3 that are not clearly related to disease progression

  First 28 day cycle

Secondary Outcomes (2)

• Number of patients with adverse events as a measure of tolerability

  Day 28 of each cycle

• Tumor progression

  Completion of every two 28 day cycles

Study Arms (1)

SNX-5422

EXPERIMENTAL

Open label administration of SNX-5422 capsules every other day (QOD) for 21 days on a 28 day cycle. Dose escalation will be based on safety outcomes defined as 1 or less dose limiting toxicities during the first 28 day cycle at any dose level

Drug: SNX-5422

Interventions

SNX-5422 DRUG

Capsule dosed every other day for 21 days out of 28 day cycle. Dose escalation based on safety

SNX-5422

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant, non-breastfeeding females 18 years-of-age or older with histologically confirmed non-Hodgkins lymphoma, without known or clinically suspected CNS involvement, that is refractory to available therapy or for which there is no available therapy.
• No more than 4 prior lines of systemic anti-cancer therapy and no prior bone marrow transplant or stem cell transplant within 12 months of dosing, and no prior allogeneic transplant.
• Karnofsky performance score ≥60
• Life expectancy of at least 3 months.
• Adequate baseline laboratory assessments

You may not qualify if:

• Currently receiving anticancer therapy or have received anticancer therapy within the past 28 days or 5 half-lives of the anticancer therapy
• The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
• At increased risk for developing prolonged QT interval, including hypokalemia or hypomagnesemia, unless corrected to within normal limits prior to first dose of SNX-• Chronic diarrhea.
• Gastrointestinal diseases or conditions that could affect drug absorption, including gastric bypass.
• Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
• History of documented adrenal dysfunction not due to malignancy.
• Seropositive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
• History of chronic liver disease

Sponsors & Collaborators

• Esanex Inc.: lead

Study Sites (5)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Georgia Regents University Cancer Center

Augusta, Georgia, 30901, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Interventions

SNX-5422

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 9, 2012
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

US (5)