Malignant TumorPhase 2NCT00212602
ONO-7436 Phase II Study in Japan
A Phase 2 study testing ONO-7436 in people with Malignant Tumor, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
Trial summary
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- ONO-7436
- How many people
- 420 participants
- Where
- 9 sitesJapan
- Study dates
- Aug 2005to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 20 years or older
- Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours
- Patients whose performance status is 0 to 2
- Other inclusion criteria as specified in the study protocol
Who cannot join
- In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
- Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study
- Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
- Other exclusion criteria as specified in the study protocol
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chubu Region Facility
Chūbu
Chugoku Region Facility
Chugoku
Hokkaido Region Facility
Hokkaido
Hokuriku Region Facility
Hokuriku
Kanto Region Facility
Kanto
Kinki Region Facility
Kinki
Kyushu Region Facility
Kyushu
Shikoku Region Facility
Shikoku
Tohoku Region Facility
Tōhoku
About this study
Official title: ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor
- Conditions
- Malignant Tumor
- Being tested
- ONO-7436
- Keywords
- ONO-7436, Aprepitant, Vomiting, Nausea
- Medical subject headings
- Neoplasms, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7436Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient proportion of complete response (no vomiting and no rescue treatment).
Secondary outcomes (1)
Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by Ono 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212602
- Sponsor's protocol ID
- ONO-7436-01
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jun 2012
- Results posted
- No
Publications
Takahashi T, Hoshi E, Takagi M, Katsumata N, Kawahara M, Eguchi K. Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci. 2010 Nov;101(11):2455-61. doi: 10.1111/j.1349-7006.2010.01689.x.
PubMed 20718754
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan
- ClinicalTrials.gov ID
- NCT00212602
- Acronym / sponsor ID
- ONO-7436-01
- Conditions
- Malignant Tumor
- Keywords
- ONO-7436, Aprepitant, Vomiting, Nausea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 21 Sep 2005 (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 examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 20 years or older
- Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours
- Patients whose performance status is 0 to 2
- Other inclusion criteria as specified in the study protocol
Key exclusion criteria (4 listed)
- In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
- Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study
- Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
- Other exclusion criteria as specified in the study protocol
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 |
|---|---|---|
| ONO-7436 | Drug | – |
Primary outcome
Patient proportion of complete response (no vomiting and no rescue treatment).
1 secondary outcome
Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment.
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 14 Jun 2012.
- Derived from this study: PubMed 20718754Takahashi T, Hoshi E, Takagi M, Katsumata N, Kawahara M, Eguchi K. Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci. 2010 Nov;101(11):2455-61. doi: 10.1111/j.1349-7006.2010.01689.x.
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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.
Project Leader, Development Planning study director
Ono Pharmaceutical Co., Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-7436 in people with Malignant Tumor, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
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 4 inclusion and 4 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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?
Patient proportion of complete response (no vomiting and no rescue treatment).. 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 NCT00212602, 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 14 Jun 2012; AzTrials last refreshed its copy on 1 Nov 2026.