A Phase 2, Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nausea Vomiting	Drug: SCH 619734 Dose 1 Drug: SCH 619734 Dose 2 Drug: SCH 619734 Dose 3 Drug: SCH 619734 Dose 4 Drug: Placebo	Phase II

MedlinePlus related topics:

Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy 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)

Further study details as provided by Schering-Plough:

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). [ Time Frame: Days 1 through 6. ] [ Designated as safety issue: No ]

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. [ Time Frame: Days 1 through 6. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	September 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SCH 619734 Dose 1: Experimental	Drug: SCH 619734 Dose 1 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 2: Experimental	Drug: SCH 619734 Dose 2 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 3: Experimental	Drug: SCH 619734 Dose 3 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 4: Experimental	Drug: SCH 619734 Dose 4 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)
Placebo: Placebo Comparator	Drug: Placebo 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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394966

Sponsors and Collaborators

Schering-Plough

Investigators


Study Director:	J. Gene Wang, M.D., Ph.D.	Schering - Plough Corporation

More Information

Responsible Party:	Schering-Plough ( Susan Arbuck, MD - Vice President, Global Clinical Research, Oncology )
Study ID Numbers:	P04351, Study ID: 3283299
First Received:	October 31, 2006
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00394966
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Signs and Symptoms

Vomiting

Signs and Symptoms, Digestive

Nausea

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00394966