Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LECPhase 2NCT01054456

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)

A Phase 2 study testing palonesetron in people with Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC, run by Eisai Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
What is being tested?: palonesetron
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 9 sitesUnited States
Study dates: 27 Oct 2009to 8 Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

In order to be eligible for enrollment, subjects must meet the following inclusion criteria:
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

Show all 34Show fewer

Scheduled to receive, on Study Day 1, a single dose of one of the qualifying LEC agents listed in the protocol.
Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the Investigator Exclusion Criteria
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
-5-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)
Butyrophenones (haloperidol, droperidol)
Cannabinoides (tetrahydrocannabinol or nabilone)
Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), with the exception of topical or inhaled preparations. Dexamethasone will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) or prevention of rash associated with pemetrexed. Prednisone will be allowed if given for as part of standard regimen with mitoxantrone or docetaxel for prostate cancer.
Any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either possibly cause nausea or vomiting, or used to treat nausea or vomiting
Having received any investigational drugs or devices within 30 days before study entry
Any vomiting, retching, or National Cancer Institute Common Terminology Criteria for Adverse Events, v.3 (NCI CTCAE) Grade 2 to 4 nausea in the 24 hours preceding chemotherapy
History of alcohol or drug abuse
Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in this protocol
Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients
Scheduled to receive or have received radiotherapy within 1 week prior to or during the study
Any condition that, in the judgment of the Principal Investigator, would make a subject ineligible for participation in the study

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Scott and White Clinic- College Station
College Station, Texas, 77840
Medical and Surgical Specialists
Galesburg, Illinois, 61401
Trover Center for Clinical Studies; Merle Mahr Cancer Center
Madisonville, Kentucky, 42431
Signal Point Clinical Research
Middletown, Ohio, 45042
Hematology- Oncology Associates of Rockland, PC
Nyack, New York, 10960
Scott and White Healthcare- Round Rock
Round Rock, Texas, 76559
Orchard Healthcare Research Inc
Skokie, Illinois, 60076
Sheridan Clinical Research
Sunrise, Florida, 33323
Scott and White Memorial Hospital
Temple, Texas, 76508

Other trials in United States

About this study

Official title: 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)

Read the detailed description

Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat CINV caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV 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.

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
Being tested: palonesetron
Keywords: LEC, Low Emetogenic Chemotherapy, Nausea and Vomiting, Nausea, Vomiting, Anti- emetic
Medical subject headings: Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

palonesetronDrug
One dose administered intravenously 30 minutes pre-chemotherapy

Study groups in NCT01054456
Study group	Role	What they receive
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. Receives: Drug: palonesetron

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
CR was defined as the participants without any emetic episodes and did not use any rescue medication. 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.
Measured: 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
CR was defined as the participants without any emetic episodes and did not use any rescue medication. 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.
Measured: 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
Complete Control was defined as the percentage of participants who had a CR and no more than mild nausea. CR was defined as the participants without any emetic episodes and did not use any rescue medication. 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 episod es and no use of rescue medication were considered to have CR during the period. Those same participants were considered complete control for the period if they had no more than mild nausea during the period.
Measured: 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
Complete Control was defined as the percentage of participants who had a CR and no more than mild nausea. CR was defined as the participants without any emetic episodes and did not use any rescue medication. 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 episod es and no use of rescue medication were considered to have CR during the period. Those same participants were considered complete control for the period if they had no more than mild nausea during the period.
Measured: 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
Complete Control was defined as the percentage of participants who had a CR and no more than mild nausea. CR was defined as the participants without any emetic episodes and did not use any rescue medication. 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 episod es and no use of rescue medication were considered to have CR during the period. Those same participants were considered complete control for the period if they had no more than mild nausea during the period.
Measured: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1
Percentage of Participants With No Emetic Episodes 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
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.
Measured: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
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.
Measured: 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 No Emetic Episodes During 0 to 48 Hours, 0 to 72 Hours, and 0 to 96 Hours After Receiving Treatment on Day 1
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.
Measured: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1
Percentage of Participants With Nausea Based on Severity and Intensity 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
The 4-point Likert scale was used to measure the severity and intensity of nausea. The participant was asked "How much nausea did you experience on average during the last 24 hours?" The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Measured: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
The 4-point Likert scale was used to measure the severity and intensity of nausea. The participant was asked "How much nausea did you experience on average during the last 24 hours?" The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Measured: 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 Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
The 4-point Likert scale was used to measure the severity and intensity of nausea. The participant was asked "How much nausea did you experience on average during the last 24 hours?" The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Measured: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1
Mean Change From Follow Up Period (Day 2-5) in Scores on Functional Living Index-Emesis [FLIE] Assessment Questionnaires to the End of Study (Day 8)
FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of >108 defines those patients who had a minimal impact of Chemotherapy-Induced Nausea and Vomiting (CINV) on quality of life.
Measured: From (Day 2-5) to the End of Study (Day 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 20098 Dec 2010

First posted22 Jan 2010 (estimated)
Study start27 Oct 2009
Primary completion8 Dec 2010
Study completion8 Dec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LECStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01054456
Sponsor's protocol ID: PALO-08-13
Status last verified: Jan 2011
First submitted: 20 Jan 2010
Last updated: 23 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22733373

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01054456
Acronym / sponsor ID: PALO-08-13
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: 27 Oct 2009 (actual)
Primary completion: 8 Dec 2010 (actual)
Study completion: 8 Dec 2010 (actual)
First posted: 22 Jan 2010 (estimated)
Results: Posted 23 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Participants: Palonosetron 0.25 mg/5 mL	Experimental	Drug: palonesetronParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (34 listed)

In order to be eligible for enrollment, subjects must meet the following inclusion criteria:
Provide written informed consent
Male or female ≥18 years of age
Histologically or cytologically confirmed malignant disease
Karnofsky Index of 50%

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
palonesetronOne dose administered intravenously 30 minutes pre-chemotherapy	Drug	All Participants: Palonosetron 0.25 mg/5 mL

Primary outcome

Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1
Time frame: From 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.
Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1
Time frame: From 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.
Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Time frame: From 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.

12 secondary outcomes

Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1
Percentage of Participants With No Emetic Episodes 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
Time frame: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
Time frame: 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 No Emetic Episodes During 0 to 48 Hours, 0 to 72 Hours, and 0 to 96 Hours After Receiving Treatment on Day 1
Time frame: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1
Percentage of Participants With Nausea Based on Severity and Intensity 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
Time frame: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
Time frame: 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 Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
Time frame: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1
Mean Change From Follow Up Period (Day 2-5) in Scores on Functional Living Index-Emesis [FLIE] Assessment Questionnaires to the End of Study (Day 8)
Time frame: From (Day 2-5) to the End of Study (Day 8)

Results and safety

Results posted to the registry on 23 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants: Palonosetron 0.25 mg/5 mL	36	35

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

Time frame: From 0 to 24 hours after receiving treatment on Day 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Participants: Palonosetron 0.25 mg/5 mL n = 34
Value	88.2 (72.5 to 96.7)

Population analysed: The intent-to-treat (ITT) population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.

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

Time frame: From 24 to 120 hours after receiving treatment on Day 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Participants: Palonosetron 0.25 mg/5 mL n = 34
Value	67.6 (49.5 to 82.6)

Population analysed: The ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.

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

Time frame: From 0 to 120 hours after receiving treatment on Day 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	All Participants: Palonosetron 0.25 mg/5 mL n = 34
Value	67.6 (49.5 to 82.6)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of administration of study drug (Day 1) up to 192 hours (Day 8). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants: Palonosetron 0.25 mg/5 mL	3 of 36 (8.3%)	13 of 36 (36.1%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22733373Hesketh 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1 (time frame: From 0 to 24 hours after receiving treatment on Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01054456, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.