Chemotherapy-Induced Nausea and VomitingPhase 2NCT00666783
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
A Phase 2 study testing palonosetron and Granisetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Xijing Hospital at 1 site in China.
Trial summary
This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- palonosetron and Granisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
- naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
- Karnofsky index more than 70% and anticipated survival time more than 90 days
- Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
- No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
- Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
- Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
- Provision of written informed consent
Who cannot join
- Inability to understand or cooperate with study procedures
- Receipt of investigational drugs 30 days before study entry
- Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
- Contraindications to 5-HT3 receptor antagonists
- Woman Patient with Pregnancy or lactation
- Diagnosed with hypertension or severe infectious diseases
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- Obstructive symptom of gastrointestinal tract
- Symptomatic brain metastasis or mental dysfunction
- Baseline QTc > 500 ms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients
This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Being tested
- palonosetron, Granisetron
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palonosetronDrug
receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.
GranisetronDrug
receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PAL | Experimental | receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) Receives: Drug: palonosetron |
| GRA | Active comparator | receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) Receives: Drug: Granisetron |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Xijing 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666783
- Sponsor's protocol ID
- 2006L01595
- Status last verified
- Aug 2006
- First submitted
- 23 Apr 2008
- Last updated
- 25 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients
- ClinicalTrials.gov ID
- NCT00666783
- Acronym / sponsor ID
- 2006L01595
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- First posted
- 25 Apr 2008 (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 clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAL | Experimental | Drug: palonosetronreceive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) |
| GRA | Active comparator | Drug: Granisetronreceive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
- naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
- Karnofsky index more than 70% and anticipated survival time more than 90 days
- Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
- No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
Key exclusion criteria (9 listed)
- Inability to understand or cooperate with study procedures
- Receipt of investigational drugs 30 days before study entry
- Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
- Contraindications to 5-HT3 receptor antagonists
- Woman Patient with Pregnancy or lactation
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 |
|---|---|---|
| palonosetronreceive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy. | Drug | PAL |
| Granisetronreceive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy. | Drug | GRA |
Primary outcome
Not reported in the source record.
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 25 Apr 2008.
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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.
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 and Granisetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Xijing Hospital 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 8 inclusion and 9 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 25 Apr 2008. 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.
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 25 Apr 2008.