Back to resultsA Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCH 619734 Dose 1
SCH 619734 Dose 2
SCH 619734 Dose 3
SCH 619734 Dose 4
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Nausea
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SCH 619734 Dose 1
SCH 619734 Dose 2
SCH 619734 Dose 3
SCH 619734 Dose 4
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
The key secondary safety endpoints are adverse events, physical examinations, vital signs, electrocardiograms, and safety laboratory values.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00394966
Brief Title
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Schering-Plough
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCH 619734 Dose 1
Arm Type
Experimental
Arm Title
SCH 619734 Dose 2
Arm Type
Experimental
Arm Title
SCH 619734 Dose 3
Arm Type
Experimental
Arm Title
SCH 619734 Dose 4
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SCH 619734 Dose 1
Other Intervention Name(s)
Rolapitant
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
SCH 619734 Dose 2
Other Intervention Name(s)
Rolapitant
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
SCH 619734 Dose 3
Other Intervention Name(s)
Rolapitant
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
SCH 619734 Dose 4
Other Intervention Name(s)
Rolapitant
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
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