A Multicenter, Open-Label, Single-Arm Evaluation of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)
Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting
associated with initial and repeat chemotherapy induced nausea and vomiting (CINV) caused by
moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and
efficacy of palonesetron in preventing CINV (Chemotherapy-Induced Nausea and Vomiting) when
administered to patients who have experienced either vomiting and or at least moderate
nausea during their last cycle of low emetogenic chemotherapy.
Palonosetron will be given intravenously approximately 30 minutes prior to the start of the
chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or
vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in
patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will
also be completed in order to help evaluate the patient's quality of life from the start of
the chemotherapy cycle through Day 6.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Complete Response rate (defined as no emetic episodes and no rescue medication)
For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall).
Yes
Raza Ahmed
Study Director
Eisai Inc.
United States: Food and Drug Administration
PALO-08-13
NCT01054456
November 2009
October 2010
Name | Location |
---|---|
Scott and White Memorial Hospital | Temple, Texas 76508 |
Medical and Surgical Specialists | Galesburg, Illinois 61401 |
Signal Point Clinical Research | Middletown, Ohio 45042 |
Sheridan Clinical Research | Sunrise, Florida 33323 |
Orchard Healthcare Research Inc | Skokie, Illinois 60076 |
Trover Center for Clinical Studies; Merle Mahr Cancer Center | Madisonville, Kentucky 42431 |
Hematology- Oncology Associates of Rockland, PC | Nyack, New York 10960 |
Scott and White Clinic- College Station | College Station, Texas 77840 |
Scott and White Healthcare- Round Rock | Round Rock, Texas 76559 |