A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)

NCT01054456 | Completed Phase 2 Results

• 1 other identifier: PALO-08-13
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 9

Brief Summary

This study is designed to assess the safety and efficacy of palonesetron in preventing chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.

Conditions

Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC

Keywords

LEC; Low Emetogenic Chemotherapy; Nausea and Vomiting; Nausea; Vomiting; Anti- emetic

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1

  CR was defined as the participants without any emetic episodes and did not use any rescue medication during acute period (0-24 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.

  From 0 to 24 hours after receiving treatment on Day 1

• Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1

  CR was defined as the participants without any emetic episodes and did not use any rescue medication during delayed period (24-120 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.

  From 24 to 120 hours after receiving treatment on Day 1

• Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1

  CR was defined as the participants without any emetic episodes and did not use any rescue medication during overall period (0-120 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.

  From 0 to 120 hours after receiving treatment on Day 1

Secondary Outcomes (12)

• Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1

  From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1

• Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1

  From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1

• Percentage of Participants With Complete Control During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1

  From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1

• Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1

  From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1

• Percentage of Participants With Complete Control During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1

  From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1

Study Arms (1)

All Participants: Palonosetron 0.25 mg/5 mL

EXPERIMENTAL

Participants will receive palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.

Drug: palonesetron

Interventions

palonesetron DRUG

One dose administered intravenously 30 minutes pre-chemotherapy

All Participants: Palonosetron 0.25 mg/5 mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• Male or female ≥18 years of age
• Histologically or cytologically confirmed malignant disease
• Karnofsky Index of 50%
• Experienced either vomiting and/or at least moderate nausea during their last cycle of LEC
• Scheduled to receive, on Study Day 1, a single dose of one of the qualifying LEC agents listed in the protocol.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• Inability or unwillingness to understand or cooperate with the study procedures as determined by the Investigator
• Women who are pregnant, nursing or planning to become pregnant, women of childbearing potential who are not using an effective method of pregnancy prevention (including implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence), or women who have had a positive serum pregnancy test at screening or within 7 days prior to receiving chemo on Day 1. Non-childbearing potential includes women who are post-menopausal (12 months of amenorrhea with no other demonstrable cause, in the appropriate age group) or documented surgical sterilization, or hysterectomy at least 3 months before study start.
• Previous use of palonosetron in association with a LEC regimen
• Received more than one antiemetic agent for prevention of CINV (Chemotherapy-Induced Nausea and Vomiting) during their last cycle of LEC (other than dexamethasone or prednisone as outlined in number 7 below). The use of an antiemetic in addition to a corticosteroid during the last cycle of LEC is allowed if the corticosteroid is intended for the prophylactic treatment of taxane-related hypersensitivity or pemetrexed-related skin reactions as long as the corticosteroid regimen remains unchanged during the trial
• Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food poisoning, gastroenteritis, etc)
• Received any drug with potential anti-emetic effect within 24 hours prior to the start of qualifying LEC agent
• Scheduled to receive an antiemetic (with the exception of administration of the palonosetron) at any time during the trial, listed below
• HT3 receptor antagonists
• NK1 receptor antagonists
• Dopamine receptor antagonists (metoclopramide)
• Phenothiazine anti-emetics (prochlorperazine, promethazine, thiethylperazine and perphenazine)
• Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) and ixabepilone
• All benzodiazepines except Triazolam or Zolpidem used once at night time due to sleep disturbances
• Atypical antipsychotic agents with compazine-like activity (e.g., olanzapine, risperidone)

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (9)

Sheridan Clinical Research

Sunrise, Florida, 33323, United States

Location

Medical and Surgical Specialists

Galesburg, Illinois, 61401, United States

Location

Orchard Healthcare Research Inc

Skokie, Illinois, 60076, United States

Location

Trover Center for Clinical Studies; Merle Mahr Cancer Center

Madisonville, Kentucky, 42431, United States

Location

Hematology- Oncology Associates of Rockland, PC

Nyack, New York, 10960, United States

Location

Signal Point Clinical Research

Middletown, Ohio, 45042, United States

Location

Scott and White Clinic- College Station

College Station, Texas, 77840, United States

Location

Scott and White Healthcare- Round Rock

Round Rock, Texas, 76559, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Related Publications (1)

• Hesketh PJ, Morrow G, Komorowski AW, Ahmed R, Cox D. Efficacy and safety of palonosetron as salvage treatment in the prevention of chemotherapy-induced nausea and vomiting in patients receiving low emetogenic chemotherapy (LEC). Support Care Cancer. 2012 Oct;20(10):2633-7. doi: 10.1007/s00520-012-1527-3. Epub 2012 Jun 24.

  PMID: 22733373 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

1-888-422-4743

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: October 27, 2009
• Primary Completion: December 8, 2010
• Study Completion: December 8, 2010
• Last Updated: December 23, 2020
• Results First Posted: December 23, 2020

Record last verified: 2011-01

Locations

US (9)