NeoplasmsPhase 4ESPNVNCT01481831
Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
A Phase 4 study testing Palonosetron Hydrochloride in people with Neoplasms and Chemotherapy-Induced Nausea and Vomiting, run by Shanghai Changzheng Hospital at 18 sites in China.
Trial summary
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms, Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- Palonosetron Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 18 sitesChina
- Study dates
- Jul 2011to Aug 2012
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
- The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
- Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
- WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
- Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
- Patients that voluntarily sign the consent form.
Who cannot join
- Pregnancy, or patients during breast feeding;
- Patients have accepted any radiotherapy during the experimental period;
- Gastric outlet or intestinal obstruction;
- Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- Patients have epilepsy, or have been used psychotropic drug and calm drug;
- Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
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- Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
- Patients have known hypersensitivity to 5-HT3 antagonists;
- Patients have chemotherapy contraindications;
- Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality
Chinese PLA 301 Hospital
Beijing, Beijing Municipality
Chinese PLA 307 Hospital
Beijing, Beijing Municipality
Chinese PLA Navy General Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The First People's Hospital of Changzhou
Changzhou, Jiangsu
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian
Anhui Provincial Hospital
Hefei, Anhui
Shandong Cancer Hospital
Jinan, Shandong
Shandong Provincial Hospital
Jinan, Shandong
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu
Guangxi Cancer Hospital
Nanning, Guangxi
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The Fourth People's Hospital of Wuxi
Wuxi, Jiangsu
Tangdu Hospital of Fourth Military Medical University
Xian, Shanxi
About this study
Official title: A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
Read the detailed description
Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2, Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program.
Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2, Cisplatin≥50mg/m2.
Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.
- Being tested
- Palonosetron Hydrochloride
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron HydrochlorideDrug
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Palonosetron HydrochlorideDrug
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
| Study group | Role | What they receive |
|---|---|---|
| H PALO day 1 | Active comparator | Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 Receives: Drug: Palonosetron Hydrochloride |
| H PALO day 1,3,5 | Experimental | Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 Receives: Drug: Palonosetron Hydrochloride |
| M PALO day 1 | Active comparator | Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 Receives: Drug: Palonosetron Hydrochloride |
| M PALO day 1,3,5 | Experimental | Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 Receives: Drug: Palonosetron Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response rate
defined as no emetic episode and no use of rescue medication
Measured: 2-7 days
Secondary outcomes (1)
Complete Response rate
defined as no emetic episode and no use of rescue medication
Measured: 0-24 hours, 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
- Responsible party
- Principal investigator, Zhan Wang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481831
- Sponsor's protocol ID
- zhiruo
- Acronym
- ESPNV
- Status last verified
- Dec 2012
- First submitted
- 28 Oct 2011
- Last updated
- 31 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China
- ClinicalTrials.gov ID
- NCT01481831
- Acronym / sponsor ID
- ESPNV / zhiruo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- First posted
- 30 Nov 2011 (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.
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
Detailed description
Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2, Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program.
Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2, Cisplatin≥50mg/m2.
Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H PALO day 1 | Active comparator | Drug: Palonosetron HydrochlorideHighly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 |
| H PALO day 1,3,5 | Experimental | Drug: Palonosetron HydrochlorideHighly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 |
| M PALO day 1 | Active comparator | Drug: Palonosetron HydrochlorideModerately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 |
| M PALO day 1,3,5 | Experimental | Drug: Palonosetron HydrochlorideModerately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
- The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
- Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
- WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
- Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
Key exclusion criteria (10 listed)
- Pregnancy, or patients during breast feeding;
- Patients have accepted any radiotherapy during the experimental period;
- Gastric outlet or intestinal obstruction;
- Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- Patients have epilepsy, or have been used psychotropic drug and calm drug;
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 |
|---|---|---|
| Palonosetron Hydrochloride0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent. | Drug | H PALO day 1, M PALO day 1 |
| Palonosetron Hydrochloride0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent. | Drug | H PALO day 1,3,5, M PALO day 1,3,5 |
Primary outcome
Complete Response rate
Time frame: 2-7 days
defined as no emetic episode and no use of rescue medication
1 secondary outcome
Complete Response rate
Time frame: 0-24 hours, 0-7 days
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 31 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palonosetron Hydrochloride in people with Neoplasms and Chemotherapy-Induced Nausea and Vomiting, run by Shanghai Changzheng Hospital at 18 sites in China.
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 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 rate (time frame: 2-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2012.