Clinical Trial VICCHEM1392
A Phase 1, Open-label, Dose-Escalation Study of the Safety of SNX-5422 Mesylate in Subjects with Refractory Hematological Malignancies
- Protocol No. VICCHEM1392
- Open Date: 03/12/2014
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: To characterize the safety profile of SNX-5422 when administered once every other day for 21 days (total=11 doses) of 28-day schedule.
- Disease Sites: Leukemia; Lymphoma; Multiple Myeloma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: SNX-5422
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01635712
- Secondary Protocol No: SNX-5422-CLN1-005
Patients are being asked to take part in this research study because they have cancer that has not responded to other treatments and no other treatments are available. This study will involve treatment with an experimental drug called SNX-5422 mesylate (referred to simply as SNX-5422). The main purpose of this study is to determine the highest dose of SNX-5422 that can be tolerated when given once every other day for 21 days. Other goals of this study are to study its side effects, to measure its possible effects on the tumor, and to further study how this drug works.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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
• 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