PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of
palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic
drug), both given with oral dexamethasone. The objective of the study is to demonstrate that
oral palonosetron 0. 50 mg is as effective as (non-inferior to) palonosetron IV 0. 25 mg to
prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24
hours after administration of a single cycle of highly emetogenic chemotherapy.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is
permitted.
- Diagnosed with a malignant solid tumor and scheduled to receive first course of
cytotoxic chemotherapy with cisplatin administered as a single I. V. dose of equal or
more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with
other chemotherapeutic agents.
- If scheduled to receive combination regimens, non-cisplatin agents of moderate to
high emetogenic potential are allowed and they must be administered following the
cisplatin infusion and completed no more than 6 hours after the initiation of
cisplatin infusion.
- If scheduled to receive chemotherapy agents of minimal to low emetogenic potential,
they are to be given on Day 1 following cisplatin or on any subsequent study day.
- ECOG Performance Status of 0, 1, or 2
- Female patients of either non-childbearing potential or child-bearing potential with
a commitment to use contraceptive methods throughout the clinical trial
- Hematologic and metabolic status adequate for receiving a highly emetogenic
cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets,
Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
- If a patient has a known hepatic or renal impairment, he/she may be enrolled in this
study at the discretion of the Investigator.
- If a patient has a known history or predisposition to cardiac conduction interval
abnormalities he/she may be enrolled in this study at the discretion of the
Investigator.
Exclusion Criteria:
- If female, pregnant or lactating.
- Current use of illicit drugs or current evidence of alcohol abuse.
- Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to
Day 5 following cisplatin administration.
- Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis
within 1 week prior to Day 1 or between Days 1 to 5.
- Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
- Symptomatic primary or metastatic CNS malignancy.
- Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial
pressure, hypercalcemia, an active infection or any uncontrolled medical conditions
(other than malignancy) that, in the opinion of the investigator, may confound the
results of the study, represent another potential etiology for emesis and nausea
(other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks
in administering the study drugs to the patient.
- Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e. g.,
palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or
dexamethasone.
- Participation in a clinical trial involving palonosetron.
- Any investigational drugs (other than those given in this study) taken within 4 weeks
prior to Day 1, and/or is scheduled to receive any investigational drug during the
study.
- Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However
topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone
daily or its equivalent are permitted.
- Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
- Any medication with known or potential antiemetic activity within 24 hours prior to
Day 1
Instituto Oncológico de Córdoba (IONC), Cordoba X5006HBF, Argentina
Clínica Universitaria Reina Fabiola, Córdoba X5004FHP, Argentina
Instituto Médico CER [Oncology], Quilmes B1878DVB, Argentina
Sanatorio Parque, Rosario 2000, Argentina
Centro Medico San Roque, San Miguel de Tucuman T4000AIK, Argentina
ISIS Clinica Especializada, Santa Fe 3000, Argentina
MHAT Dr. Tota Venkova, Gabrovo 5300, Bulgaria
District Dispensery for Oncology Diseases with in-patient, Sofia 6300, Bulgaria
Specialised Hospital for Active treatment on Oncology, Sofia 1756, Bulgaria
Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department, Sofia 1233, Bulgaria
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic, Sofia 1572, Bulgaria
Complex Oncology Centre, Stara Zagora 6003, Bulgaria
Klinicki bolnicki centar [Oncology], Osijek 31000, Croatia
KBC Rijeka, Rijeka 51000, Croatia
Opca bolnica Varazdin, Varazdin 42000, Croatia
KBC Zagreb, Zagreb 10000, Croatia
Klinicka bolnica [Sestre milosrdnice], Zagreb 10000, Croatia
Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte, Berlin 10117, Germany
OncoResearch Lerchenfeld UG, Hamburg 22081, Germany
Staedtisches Krankenhaus Muenchen Neuperlach, München 81737, Germany
Städtisches Klinikum München, München 81545, Germany
Fővárosi Önkormányzat Uzsoki utcai Kórház, Budapest 1145, Hungary
Semmelweis Egyetem Kútvölgyi Klinikai Tömb, Budapest 1125, Hungary
Petz Aladár Megyei Oktató Kórház, Györ 9024, Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged, Kecskemet 6000, Hungary
Pécsi Tudományegyetem [Onkoterápiás Intézet], Pécs 7624, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz, Szolnok 5004, Hungary
Chinmaya Mission Hospital, Bangalore 632004, India
Sri Venkateshwara Hospital [Medical Oncology], Bangalore 560068, India
Yashoda Super speciality Hospital, Hyderabad Andhra Pradesh 500 082, India
Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation, Maharashtra 444605, India
Apollo Speciality Hospital, Tamil Nadu 600035, India
City Cancer Centre [Surgical and Medical Oncology], Vijayawada 520002, India
Fondazione Poliambulanza Istituto Ospedaliero, Brescia 25124, Italy
Ospedale Vito Fazzi - ASL Lecce, Lecce 73100, Italy
Presidio Ospedaliero "Alessandro Manzoni", Lecco 23900, Italy
AO Regionale S.Carlo di Potenza, Potenza 85100, Italy
Szpital Wojewodzki Zespolony, Elblag 82-300, Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Lodz 93-509, Poland
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego, Lomza 18-400, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka, Slupsk 76-200, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie, Warszawa 02-781, Poland
NZOZ Magodent - Centrum Medczyne Ostrobramska, Warszawa 04-125, Poland
Spitalul Judetean de Urgenta "Dr. Constantin Opris", Baia-Mare 430031, Romania
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu", Bucharest 22328, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj-Napoca 400015, Romania
Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala), Cluj-Napoca 400349, Romania
Centrul de Oncologie Euroclinic, Iasi 700106, Romania
Institutul Regional de Oncologie Iasi, Iasi 700483, Romania
Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie], Sibiu 550245, Romania
Oncomed SRL, Timisoara 300239, Romania
GUZ Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk 163045, Russian Federation
GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F., Krasnoyarsk 660022, Russian Federation
GUZ Lipetsk Regional Oncology Dispensary [General Oncology], Lipetsk 398005, Russian Federation
GUZ Regional Oncology Dispensary #2, Magnitogorsk 455001, Russian Federation
RAMN - Russian Cancer Research Center, Moscow 115478, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin RAMN, Moscow 115478, Russian Federation
MBUZ City Clinical Hospital #1 [Oncology], Novosibirsk 630047, Russian Federation
FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF, Obninsk 249036, Russian Federation
Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio, Ryazan 390026, Russian Federation
GUZ Leningrad Regional Oncological Dispensary, Saint Petersburg 188663, Russian Federation
St. Petersburg Clinical Oncology Dispesary, Saint Petersburg 197022, Russian Federation
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi, Chernigiv 14029, Ukraine
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4, Dnipropetrovsk 49102, Ukraine
Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad, Donetsk 83092, Ukraine
DU IMR AMNU [vd khemter], Kharkiv 61024, Ukraine
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr, Kharkiv 61070, Ukraine
Chmelnytskyi Regional Clinical Oncology Centre [Oncology], Khmelnytskyi 29009, Ukraine
Uzhgorod National University, Uzhgorod 88000, Ukraine
Genesis Cancer Centre, Hot Springs, Arkansas 71913, United States
Centro Oncológico Integral (COI), Mar del Plata, Buenos Aires 7600, Argentina
Compassionate Cancer Center, Corona, California 92879, United States
Compassionate Cancer Centre Medical Group, Fountain Valley, California 92708, United States
Facey Medical Group, Mission Hills, California 91345, United States
Compassionate Cancer Care Medical Group, Riverside, California 92501, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio 45042, United States
Wellmont Medical Associates-Oncology and Hematology, Bristol, Rhode Island 37620, United States
Charleston Hematology Oncology, Charleston, South Carolina 29414, United States
Northern Utah Associates [Hematology/ Oncology], Ogden, Utah 84403, United States