Chemotherapy-Induced Nausea and VomitingPhase 3NCT00359567
Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy
A Phase 3 study testing palonosetron and granisetron hydrochloride in people with Chemotherapy-Induced Nausea and Vomiting, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- palonosetron and granisetron hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2006to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 or more at the time when they give consent.
- Diagnosed as malignant disease.
- Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
- Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
- WBC ≥ 3000 /mm3 AST < 100 IU/L ALT < 100 IU/L Creatinine clearance ≥ 60 mL/min
- Performance Status : 0 - 2
Who cannot join
- Severe (requiring hospitalization) and uncontrollable complications.
- Metastases to the brain which are symptomatic.
- Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
- Symptomatic and invasive procedure indicated ascites or pleural effusion.
- Have either gastric outlet stenosis or intestinal obstruction.
- Have ongoing emesis or CTCAE grade 2 or greater nausea.
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- QTc > 470 msec in the 12-lead ECG within eight days before registration.
- Known anaphylactic to ingredients of the study drug, namely palonosetron or granisetron hydrochloride injection, or other 5-HT3 receptor antagonists.
- Known anaphylactic to ingredients of dexamethasone.
- Pregnant women, breast-feeding women, or any male or female who are not willing to practice adequate contraception during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy
To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.
Read the detailed description
This study involves prophylactic single dose of granisetron hydrochloride as a control in the treatment of chemotherapy induced nausea and vomiting (CINV). The primary objective of the study is to verify 0.75 mg palonosetron, concomitantly administered with corticosteroids, is not inferior and superior to granisetron hydrochloride in acute stages 0 - 24 hours and in delayed stages 24 - 120 hours after administration of highly emetogenic chemotherapy, respectively. Corticosteroids are commonly employed in current medical treatments with 5-HT3 receptor antagonists.
This is a multicenter, parallel, group comparative study where subjects are assigned to treatment groups in accordance with a central registration system. After obtaining written informed consent, the patients that satisfy the inclusion criteria without meeting the exclusion criteria are assigned using minimizing procedures to either a single-dose of 0.75 mg palonosetron group or a single-dose of 40 μg/kg granisetron hydrochloride with covariates of chemotherapy regimen, gender and age. A palonosetron group will receive intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy. A granisetron hydrochloride group will be treated with palonosetron placebo and then intravenous 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy. The onset of nausea and emetic episodes and the time of an antiemetic procedure will be observed for 120 hours after the start of highly emetogenic chemotherapy. The objective is to find the patients' global satisfaction with the antiemetic therapy. Adverse events will also be observed for seven days after the administration of the each drug.
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Being tested
- palonosetron, granisetron hydrochloride
- Keywords
- nausea and vomiting
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palonosetronDrug
intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
granisetron hydrochlorideDrug
intravenous injections of palonosetron placebo and then 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | palonosetron Receives: Drug: palonosetron |
| 2 | Active comparator | granisetron hydrochloride Receives: Drug: granisetron hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting
Secondary outcomes (1)
Safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tomohide Tamura, MD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359567
- Sponsor's protocol ID
- 10037030-01
- Status last verified
- Jul 2011
- First submitted
- 1 Aug 2006
- Last updated
- 7 Jul 2011
- Results posted
- No
Publications
Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol. 2009 Feb;10(2):115-24. doi: 10.1016/S1470-2045(08)70313-9. Epub 2009 Jan 8.
PubMed 19135415
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT00359567
- Acronym / sponsor ID
- 10037030-01
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Keywords
- nausea and vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.
Detailed description
This study involves prophylactic single dose of granisetron hydrochloride as a control in the treatment of chemotherapy induced nausea and vomiting (CINV). The primary objective of the study is to verify 0.75 mg palonosetron, concomitantly administered with corticosteroids, is not inferior and superior to granisetron hydrochloride in acute stages 0 - 24 hours and in delayed stages 24 - 120 hours after administration of highly emetogenic chemotherapy, respectively. Corticosteroids are commonly employed in current medical treatments with 5-HT3 receptor antagonists.
This is a multicenter, parallel, group comparative study where subjects are assigned to treatment groups in accordance with a central registration system. After obtaining written informed consent, the patients that satisfy the inclusion criteria without meeting the exclusion criteria are assigned using minimizing procedures to either a single-dose of 0.75 mg palonosetron group or a single-dose of 40 μg/kg granisetron hydrochloride with covariates of chemotherapy regimen, gender and age. A palonosetron group will receive intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy. A granisetron hydrochloride group will be treated with palonosetron placebo and then intravenous 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy. The onset of nausea and emetic episodes and the time of an antiemetic procedure will be observed for 120 hours after the start of highly emetogenic chemotherapy. The objective is to find the patients' global satisfaction with the antiemetic therapy. Adverse events will also be observed for seven days after the administration of the each drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: palonosetronpalonosetron |
| 2 | Active comparator | Drug: granisetron hydrochloridegranisetron hydrochloride |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 20 or more at the time when they give consent.
- Diagnosed as malignant disease.
- Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
- Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
- WBC ≥ 3000 /mm3 AST < 100 IU/L ALT < 100 IU/L Creatinine clearance ≥ 60 mL/min
Key exclusion criteria (10 listed)
- Severe (requiring hospitalization) and uncontrollable complications.
- Metastases to the brain which are symptomatic.
- Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
- Symptomatic and invasive procedure indicated ascites or pleural effusion.
- Have either gastric outlet stenosis or intestinal obstruction.
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 |
|---|---|---|
| palonosetronintravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids. | Drug | 1 |
| granisetron hydrochlorideintravenous injections of palonosetron placebo and then 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids. | Drug | 2 |
Primary outcome
Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting
1 secondary outcome
Safety profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
- Results publication: PubMed 19135415Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol. 2009 Feb;10(2):115-24. doi: 10.1016/S1470-2045(08)70313-9. Epub 2009 Jan 8.
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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.
Tomohide Tamura, MD principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing palonosetron and granisetron hydrochloride in people with Chemotherapy-Induced Nausea and Vomiting, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
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 6 inclusion and 10 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 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting. 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 NCT00359567, 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 7 Jul 2011.