NauseaPhase 2NCT00394966
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
A Phase 2 study testing SCH 619734 Dose 1, SCH 619734 Dose 2 and SCH 619734 Dose 3 in people with Nausea and Vomiting, run by Schering-Plough.
Trial summary
This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SCH 619734 Dose 1, SCH 619734 Dose 2 and SCH 619734 Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older.
- Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (>=70 mg/m^2).
- Subject has a Karnofsky performance score of >=60.
- Subject has a predicted life expectancy of >=3 months.
- Subject has adequate bone marrow, kidney, and liver function as evidenced by:
- Absolute neutrophil count >=1,500/mm3 and white blood cell count >=3,000/mm3.
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- Platelet count >=100,000/mm3.
- Aspartate aminotransferase (AST) <=2.5 x upper limit of normal (ULN) range.
- Alanine aminotransferase (ALT) <=2.5 x ULN.
- Bilirubin <=1.5 x ULN, except for subjects with Gilbert's syndrome.
- Creatinine <=1.5 x ULN.
- Subject is able to read, understand, and complete the questionnaires.
Who cannot join
- Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
- Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
- Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6.
- Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
- Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
- Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.
About this study
Official title: A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.
- Being tested
- SCH 619734 Dose 1, SCH 619734 Dose 2, SCH 619734 Dose 3, SCH 619734 Dose 4, Placebo
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 619734 Dose 1Drug
Also called Rolapitant
SCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
SCH 619734 Dose 2Drug
Also called Rolapitant
SCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
SCH 619734 Dose 3Drug
Also called Rolapitant
SCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
SCH 619734 Dose 4Drug
Also called Rolapitant
SCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
PlaceboDrug
Matching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)
| Study group | Role | What they receive |
|---|---|---|
| SCH 619734 Dose 1 | Experimental | Not described Receives: Drug: SCH 619734 Dose 1 |
| SCH 619734 Dose 2 | Experimental | Not described Receives: Drug: SCH 619734 Dose 2 |
| SCH 619734 Dose 3 | Experimental | Not described Receives: Drug: SCH 619734 Dose 3 |
| SCH 619734 Dose 4 | Experimental | Not described Receives: Drug: SCH 619734 Dose 4 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy).
Measured: Days 1 through 6.
Secondary outcomes (2)
The key secondary efficacy endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV.
Measured: Days 1 through 6.
The key secondary safety endpoints are adverse events, physical examinations, vital signs, electrocardiograms, and safety laboratory values.
Measured: Throughout the study and up to 30 days after the subject completes or discontinues from the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394966
- Sponsor's protocol ID
- P04351
- Other IDs
- Study ID: 3283299
- Status last verified
- Oct 2009
- First submitted
- 31 Oct 2006
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
- ClinicalTrials.gov ID
- NCT00394966
- Acronym / sponsor ID
- P04351
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 2 Nov 2006 (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 is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SCH 619734 Dose 1 | Experimental | Drug: SCH 619734 Dose 1 |
| SCH 619734 Dose 2 | Experimental | Drug: SCH 619734 Dose 2 |
| SCH 619734 Dose 3 | Experimental | Drug: SCH 619734 Dose 3 |
| SCH 619734 Dose 4 | Experimental | Drug: SCH 619734 Dose 4 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is 18 years of age or older.
- Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (>=70 mg/m^2).
- Subject has a Karnofsky performance score of >=60.
- Subject has a predicted life expectancy of >=3 months.
- Subject has adequate bone marrow, kidney, and liver function as evidenced by:
Key exclusion criteria (6 listed)
- Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
- Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
- Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6.
- Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
- Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
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 |
|---|---|---|
| SCH 619734 Dose 1Also: RolapitantSCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) | Drug | SCH 619734 Dose 1 |
| SCH 619734 Dose 2Also: RolapitantSCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) | Drug | SCH 619734 Dose 2 |
| SCH 619734 Dose 3Also: RolapitantSCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) | Drug | SCH 619734 Dose 3 |
| SCH 619734 Dose 4Also: RolapitantSCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) | Drug | SCH 619734 Dose 4 |
| PlaceboMatching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) | Drug | Placebo |
Primary outcome
The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy).
Time frame: Days 1 through 6.
2 secondary outcomes
The key secondary efficacy endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV.
Time frame: Days 1 through 6.
The key secondary safety endpoints are adverse events, physical examinations, vital signs, electrocardiograms, and safety laboratory values.
Time frame: Throughout the study and up to 30 days after the subject completes or discontinues from the study.
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 23 Oct 2009.
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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 2 study testing SCH 619734 Dose 1, SCH 619734 Dose 2 and SCH 619734 Dose 3 in people with Nausea and Vomiting, run by Schering-Plough.
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 12 inclusion and 6 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 23 Oct 2009. 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. Some participants in this study may receive a placebo. 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?
The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy). (time frame: Days 1 through 6.). 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 23 Oct 2009.