NeoplasmsPhase 4NCT00684463
Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
A Phase 4 study testing Palonosetron in people with Neoplasms and Nausea, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2007to 22 Feb 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older.
- Histological or cytological confirmation of malignant disease.
- Karnofsky index >= 50%
- Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
- Patients that voluntarily sign the consent form.
Who cannot join
- Pregnancy or suspected.
- Patients during breast feeding.
- Inability to understand or cooperate with the study procedures.
- Received any investigational drugs within 30 days before study entry.
- Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
- Seizure disorders requiring anticonvulsant medication.
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- Persistent vomiting due to any organic etiology.
- Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
- Any systemic disease different to base disease
- Known current or history of drug or alcohol abuse
- Gastric outlet or intestinal obstruction
About this study
Official title: Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
- Being tested
- Palonosetron
- Keywords
- Antiemetic
- Medical subject headings
- Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Also called SCH 734291 - Onicit®
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron | Experimental | 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent Receives: Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
Measured: During 24 hours after administration of chemotherapy.
Secondary outcomes (3)
Proportion of patients who achieved a CR and of those who achieved complete control
Measured: Days 1 to 5 at different time intervals for each secondary outcome.
Number of emetic episodes
Measured: Days 1 to 5 at different time intervals for each secondary outcome.
Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication
Measured: Days 1 to 5 at different time intervals for each secondary outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study start11 Apr 2007
- Primary completion22 Feb 2008
- Study completion22 Feb 2008
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 Merck Sharp & Dohme LLCThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684463
- Sponsor's protocol ID
- P04935
- Status last verified
- May 2017
- First submitted
- 22 May 2008
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia
- ClinicalTrials.gov ID
- NCT00684463
- Acronym / sponsor ID
- P04935
- Keywords
- Antiemetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2007 (actual)
- Primary completion
- 22 Feb 2008 (actual)
- Study completion
- 22 Feb 2008 (actual)
- First posted
- 26 May 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.
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palonosetron | Experimental | Drug: Palonosetron0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be 18 years of age or older.
- Histological or cytological confirmation of malignant disease.
- Karnofsky index >= 50%
- Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
- Patients that voluntarily sign the consent form.
Key exclusion criteria (11 listed)
- Pregnancy or suspected.
- Patients during breast feeding.
- Inability to understand or cooperate with the study procedures.
- Received any investigational drugs within 30 days before study entry.
- Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
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 |
|---|---|---|
| PalonosetronAlso: SCH 734291 - Onicit®0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent. | Drug | Palonosetron |
Primary outcome
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
Time frame: During 24 hours after administration of chemotherapy.
3 secondary outcomes
Proportion of patients who achieved a CR and of those who achieved complete control
Time frame: Days 1 to 5 at different time intervals for each secondary outcome.
Number of emetic episodes
Time frame: Days 1 to 5 at different time intervals for each secondary outcome.
Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication
Time frame: Days 1 to 5 at different time intervals for each secondary outcome.
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 16 May 2017.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palonosetron in people with Neoplasms and Nausea, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 11 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. (time frame: During 24 hours after administration of chemotherapy.). 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 16 May 2017.