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Sponsored by: |
Cytopia Research Pty Ltd |
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Information provided by: | Cytopia Research Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00664378 |
This is a clinical research study that is designed to test the safety of CYT997 when given to patients with multiple myeloma and to test if CYT997 has any activity against that cancer.
Condition | Intervention | Phase |
---|---|---|
Relapsed and Refractory Multiple Myeloma |
Drug: CYT997 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Single-Arm, Two-Stage, Open-Label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma |
Estimated Enrollment: | 24 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental
CYT997
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Drug: CYT997
Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
myocardial infarction or stroke within 6 months unstable angina pectoris or acute ischemic changes on ECG history of diabetic retinopathy symptomatic peripheral arterial disease major surgery in the last 30 days
LVEF < 45% as determined by MUGA scan or echocardiogram; complete left bundle branch block; obligate use of a cardiac pacemaker; congenital long QT syndrome; history or presence of ventricular tachyarrhythmia; presence of unstable atrial fibrillation (ventricular response > 100 bpm). Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria; clinically significant resting bradycardia (< 50 bpm); right bundle branch block + left anterior hemiblock (bifasicular block); angina pectoris ≤ 3 months prior to starting study drug; acute MI ≤ 3 months prior to starting study drug; or other clinically significant heart disease (e.g., CHF, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
Contact: Katie Boast, RN | +61392763751 | k.boast@alfred.org.au |
Australia, Victoria | |
The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Principal Investigator: Andrew Spencer, MD |
Study Chair: | Andrew Spencer, MD | The Alfred |
Responsible Party: | Cytopia Research Pty Ltd ( Dr Gregg Smith, Director: Drug Development ) |
Study ID Numbers: | CCL07001 |
Study First Received: | April 18, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00664378 |
Health Authority: | United States: Food and Drug Administration; Australia: Therapeutic Goods Administration |
Multiple myeloma, relapsed, refractory |
Immunoproliferative Disorders Hemorrhagic Disorders Multiple myeloma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |