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NauseaPhase 2NCT00503386

Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

A Phase 2 study testing Palonosetron and Granisetron in people with Nausea and Vomiting, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nausea, Vomiting, Chemotherapy
What is being tested?
Palonosetron and Granisetron
How many people
144 participants
Where
6 sitesChina
Study dates
Apr 2006to Oct 2006
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 ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed
  • Malignant disease
  • Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
  • Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1
  • Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
  • Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
Show all 9Show fewer
  • Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
  • Predicted life expectancy of ≥ 3 months
  • 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
  • Receipt of other investigational drugs during the course of this study
  • Seizure disorder or any condition requiring anticonvulsants, sedatives
  • CNS malignancy or metastasis
  • Ongoing emesis due to obstruction of digestive tract
Show all 13Show fewer
  • Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
  • Moderate or severe nausea and vomiting after any previous chemotherapy
  • Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5
  • Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
  • Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
  • Contraindications to 5-HT3 receptor antagonists
  • Contraindications to chemotherapy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Institute on Thoracic Cancer and Tuberculosis

    Beijing, 101149

  • Hunan Provincial Tumor Hospital

    Changsha, Hunan, 410006

  • Fujian Provincial Tumor Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The Second Hospital Affiliated to Zhejiang University

    Hangzhou, Zhejiang, 310009

  • Jiangsu Provincial Tumor Hospital

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Being tested
Palonosetron, Granisetron
Keywords
chemotherapy-induced nausea and vomiting, acute, delayed, emesis, antiemetics, 5-HT3 receptor antagonist, granisetron, palonosetron
Medical subject headings
Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalonosetronDrug

  • GranisetronDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)

    Measured: 0-24h, 24-120h , 0-120h following chemotherapy

Secondary outcomes (5)

  1. Major Protection from vomiting

    Measured: 0-24h,24-120h,0-120h following chemotherapy

  2. Major Protection from nausea

    Measured: 0-24h,24-120h,0-120h following chemotherapy

  3. Complete Protection from Both Vomiting and Nausea

    Measured: 0-24h,24-120h,0-120h following chemotherapy

  4. Complete Protection from Both Vomiting and Moderate-to-Severe nausea

    Measured: 0-24h,24-120h,0-120h following chemotherapy

  5. Time to First Emetic Episode

    Measured: 0-120h following chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2007 (estimated)
  2. Study startApr 2006
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00503386
Sponsor's protocol ID
HJGene_SYat-sen_06_01
Status last verified
Sep 2010
First submitted
16 Jul 2007
Last updated
17 Sep 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Tian W, Wang Z, Zhou J, Zhang S, Wang J, Chen Q, Huang C, Pan L, Zhang L, Huang J, Shen H, Lin T. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2011 Mar;28(1):71-8. doi: 10.1007/s12032-009-9398-2. Epub 2010 Jan 5.

    PubMed 20049561

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palonosetron and Granisetron in people with Nausea and Vomiting, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 6 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 9 inclusion and 13 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 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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 Protection from Vomiting (ie.Complete Response in Preventing Vomiting) (time frame: 0-24h, 24-120h , 0-120h following chemotherapy). 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 NCT00503386, 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 17 Sep 2010.

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