CancerPhase 2NCT01909856
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
A Phase 2 study testing Palonosetron, Granisetron and Dexamethasone in people with Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Palonosetron, Granisetron and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Jun 2014
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
- The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
- Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
- Life expectancy ≥ 3 months;
- Adequate hematologic function;
- Adequate hepatic function;
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- Adequate renal function;
- At least 2 weeks away from the last chemotherapy;
- Patients signed written informed consent.
Who cannot join
- Pregnant or lactating women;
- History of anticipatory vomiting;
- Radiation therapy on the abdomen or pelvis within one week prior to study entry;
- Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
- Patients with gastrointestinal obstruction;
- Patients with severe heart disease, liver or renal disease, or metabolism disorders;
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- Patients with epilepsy or using sedative or psychotropic drugs;
- Patients with diabetes or with contraindication for corticosteroids;
- Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
- Patients with brain metastasis or intracranial hypertension;
- Hypersensitivity to 5-HT3 receptor antagonist;
- Patients with active infection;
- Other conditions that the investigator considered as unsuitable for chemotherapy;
- Subjects participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.
- Conditions
- Cancer
- Being tested
- Palonosetron, Granisetron, Dexamethasone, Cisplatin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Palonosetron 0.25mg d1,d3
GranisetronDrug
Granisetron 3mg d1-3
DexamethasoneDrug
Dexamethasone 10mg d1-3
CisplatinDrug
3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | 1st cycle Palonosetron, 2nd cycle Granisetron Receives: Drug: Palonosetron; Drug: Granisetron; Drug: Dexamethasone; Drug: Cisplatin |
| Arm2 | Experimental | 1st cycle Granisetron, 2nd cycle Palonosetron Receives: Drug: Palonosetron; Drug: Granisetron; Drug: Dexamethasone; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response(CR) within 24-120 hours after chemotherapy
Measured: 24-120 hours
Secondary outcomes (3)
CR within 0-120 hours after chemotherapy
Measured: 0-120 hours
CR within 0-24 hours after chemotherapy
Measured: 0-24 hours
Incidence of Adverse events
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiying Yu, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909856
- Sponsor's protocol ID
- sim-palonosetron
- Status last verified
- Nov 2015
- First submitted
- 22 Jul 2013
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT01909856
- Acronym / sponsor ID
- sim-palonosetron
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jul 2013 (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 study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Palonosetron, Drug: Granisetron, Drug: Dexamethasone, Drug: Cisplatin1st cycle Palonosetron, 2nd cycle Granisetron |
| Arm2 | Experimental | Drug: Palonosetron, Drug: Granisetron, Drug: Dexamethasone, Drug: Cisplatin1st cycle Granisetron, 2nd cycle Palonosetron |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
- The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
- Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
- Life expectancy ≥ 3 months;
- Adequate hematologic function;
Key exclusion criteria (14 listed)
- Pregnant or lactating women;
- History of anticipatory vomiting;
- Radiation therapy on the abdomen or pelvis within one week prior to study entry;
- Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
- Patients with gastrointestinal 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 |
|---|---|---|
| PalonosetronPalonosetron 0.25mg d1,d3 | Drug | Arm1, Arm2 |
| GranisetronGranisetron 3mg d1-3 | Drug | Arm1, Arm2 |
| DexamethasoneDexamethasone 10mg d1-3 | Drug | Arm1, Arm2 |
| Cisplatin3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3 | Drug | Arm1, Arm2 |
Primary outcome
Complete Response(CR) within 24-120 hours after chemotherapy
Time frame: 24-120 hours
3 secondary outcomes
CR within 0-120 hours after chemotherapy
Time frame: 0-120 hours
CR within 0-24 hours after chemotherapy
Time frame: 0-24 hours
Incidence of Adverse events
Time frame: up to 3 months
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 4 Dec 2015.
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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.
Shiying Yu, MD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron, Granisetron and Dexamethasone in people with Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site 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 9 inclusion and 14 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 4 Dec 2015. 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 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 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?
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) within 24-120 hours after chemotherapy (time frame: 24-120 hours). 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 4 Dec 2015.