An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.

Sponsors

Lead Sponsor: Helsinn Healthcare SA

Collaborator: PSI CRO AG

Source Helsinn Healthcare SA
Brief Summary

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected 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

Overall Status Completed
Start Date October 2015
Completion Date March 2016
Primary Completion Date March 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase 0-24 hours
Secondary Outcome
Measure Time Frame
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase >24-120 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase 0-120 hours
Percentage of Patients With no Emetic Episodes in the Acute Phase 0-24 hours
Percentage of Patients With no Emetic Episodes in the Delayed Phase >24-120 hours
Percentage of Patients With no Emetic Episodes in the Overall Phase 0-120 hours
Percentage of Patients With no Rescue Medication in the Acute Phase 0-24 hours
Percentage of Patients With no Rescue Medication in the Delayed Phase >24-120 hours
Percentage of Patients With no Rescue Medication in the Overall Phase 0-120 hours
Enrollment 441
Condition
Intervention

Intervention Type: Drug

Intervention Name: Palonosetron

Intervention Type: Drug

Intervention Name: Dexamethasone

Eligibility

Criteria:

Inclusion Criteria:

- Signed written informed consent

- Histologically or cytologically confirmed solid tumor malignancy.

- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.

- Scheduled to receive first course of one of the following reference HEC, alone or in combination with other chemotherapeutic agents on Day 1:

- cisplatin administered as a single IV dose of ≥ 70 mg/m2

- cyclophosphamide ≥1500 mg/m2

- carmustine (BCNU) >250 mg/m2

- dacarbazine (DTIC)

- mechloretamine (nitrogen mustard)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .

- If a patient is female, she shall be of non-childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.

- Hematologic and metabolic status adequate for receiving an highly emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)

- Able to read, understand, follow the study procedure and complete patient diary.

Exclusion Criteria:

- Lactating woman.

- Current use of illicit drugs or current evidence of alcohol abuse.

- Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic chemotherapy from Day 2 to Day 5.

- Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference HEC administration on Day 1 or between Days 1 to 5.

- Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference HEC administration on Day 1.

- Symptomatic primary or metastatic CNS malignancy.

- Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or 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) or pose unwarranted risks in administering the study drugs to the patient.

- Known hypersensitivity or contraindication to 5-HT3 receptor antagonists

- Known contraindication to the IV administration of 50 mL 5% glucose solution.

- Participation in a previous 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 present study.

- Systemic corticosteroid therapy at any dose within 72 hours prior to the start of the reference HEC administration on Day 1. However, topical and inhaled corticosteroids 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 the start of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists

- Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy | Lesnoy, 223052, Belarus
Minsk City Clinical Oncology Center | Minsk, 220013, Belarus
University Clinical Centre of the Republic of Srpska | Banja Luka, Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology | Dobrich, 9300, Bulgaria
Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology | Haskovo, 6300, Bulgaria
Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology | Plovdiv, 4002, Bulgaria
Complex Oncology Center, Ruse, Department of Medical Oncology | Rousse, 7002, Bulgaria
Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology | Sofia, 1303, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology | Sofia, 1431, Bulgaria
Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda" | Sofia, Bulgaria
Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care | Varna, 9010, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology | Varna, 9010, Bulgaria
JSC NeoMedi | Tbilisi, 0131, Georgia
LTD Institute of Clinical Oncology | Tbilisi, 0159, Georgia
LTD Aversi Clinic | Tbilisi, 0160, Georgia
LDT High Technology Medical Center University Clinic | Tbilisi, Georgia
"Sotiria" Chest Diseases Hospital of Athens | Athens, Greece
Thermi Clinic S.A. | Thessaloniki, 570 01, Greece
General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology | Thessaloniki, 570 10, Greece
Bioclinic Thessalonikis S.A. | Thessaloniki, Greece
Koranyi National Institute of TBC and Pulmonology | Budapest, 1121, Hungary
Uzsoki Hospital, Department of Radiation Oncology | Budapest, 1145, Hungary
University of Debrecen, Medical and Health Science Center | Debrecen, Hungary
Petz Aladar County Teaching Hospital, Center for Oncoradiology | Gyor, 9024, Hungary
Kaposi Mor Teaching Hospital, Centre for Clinical Oncology | Kaposvár, 7400, Hungary
Borsod-Abauj-Zemplen County Hospital and University Educational Hospital | Miskolc, 3526, Hungary
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital | Nyíregyháza, Hungary
Medical Center of the University of Pecs | Pecs, Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology | Kaunas, 45434, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology | Kaunas, 50009, Lithuania
Oncopremium Team SRL, Department of Oncology | Baia Mare, Romania
Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II | Bucharest, 022328, Romania
Coltea Clinical Hospital, Department of Medical Oncology | Bucharest, 030171, Romania
Hifu Terramed Conformal SRL, Department of Medical Oncology | Bucharest, 031864, Romania
Ianuli Med Consult SRL, Oncology Department | Bucharest, Romania
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I | Cluj-Napoca, 400015, Romania
Radiotherapy Center Cluj SRL, Department of Oncology | Cluj-Napoca, Romania
Constanta Emergency Clinical County Hospital, Department of Medical Oncology | Constanta, 900591, Romania
Oncology Center "Sf. Nectarie", Department of Medical Oncology | Craiova, Romania
Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology | Suceava, 720237, Romania
Oncomed SRL, Department of Medical Oncology | Timisoara, 300239, Romania
Oncocenter Clinical Oncology SRL, Department of Medical Oncology | Timisoara, Romania
Arkhangelsk Clinical Oncology Center | Arkhangelsk, Russian Federation
Altay Territorial Oncology Center | Barnaul, Russian Federation
Bryansk Regional Oncology Center | Bryansk, Russian Federation
Chelyabinsk Regional Clinical Oncology Center | Chelyabinsk, Russian Federation
Evimed, LLC | Chelyabinsk, Russian Federation
Sverdlovsk Regional Oncology Center | Ekaterinburg, Russian Federation
Ivanovo Regional Oncology Center | Ivanovo, Russian Federation
Kaluga Regional Oncology Center | Kaluga, Russian Federation
Republican Clinical Oncology Center | Kazan, Russian Federation
Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center | Krasnoyarsk, Russian Federation
Moscow City Oncology Hospital #62 | Moscow, Russian Federation
Moscow Clinical Scientific and Practical Center | Moscow, Russian Federation
N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2 | Moscow, Russian Federation
N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors | Moscow, Russian Federation
N.N. Blokhin Russian Oncology Research Center | Moscow, Russian Federation
Branch #1 of Nizhny Novgorod Regional Oncology Center | Nizhny Novgorod, Russian Federation
City Clinical Hospital #1 | Novosibirsk, Russian Federation
Novosibirsk Regional Oncology Center | Novosibirsk, Russian Federation
Clinical Oncology Center, Dept. of Chemotherapy | Omsk, Russian Federation
Clinical Oncology Center | Omsk, Russian Federation
Orenburg Regional Clinical Oncology Center | Orenburg, Russian Federation
Pyatigorsk Oncology Center | Pyatigorsk, Russian Federation
Regional Clinical Oncology Center | Ryazan, Russian Federation
Samara Regional Clinical Oncology Center | Samara, Russian Federation
City Clinical Oncology Center, Thoracic Oncology Dept. | St. Petersburg, Russian Federation
City Clinical Oncology Center, Urology Oncology Dept. | St. Petersburg, Russian Federation
City Clinical Oncology Center | St. Petersburg, Russian Federation
First I.P. Pavlov State Medical University of St. Petersburg | St. Petersburg, Russian Federation
St.Petersburg Municipal Clinical Oncology Center | St. Petersburg, Russian Federation
Tambov Regional Oncology Center | Tambov, Russian Federation
Tomsk Research Institute of Oncology, General Oncology Dept. | Tomsk, Russian Federation
Tomsk Research Institute of Oncology | Tomsk, Russian Federation
Republican Clinical Oncology Center | Ufa, Russian Federation
Regional Clinical Oncology Center | Veliky Novgorod, Russian Federation
Location Countries

Belarus

Bosnia and Herzegovina

Bulgaria

Georgia

Greece

Hungary

Lithuania

Romania

Russian Federation

Verification Date

June 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: I.V. palonosetron infusion plus dexamethasone

Type: Experimental

Description: Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

Label: I.V. palonosetron bolus plus dexamethasone

Type: Active Comparator

Description: Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov