Status:
COMPLETED
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
Lead Sponsor:
Schering-Plough
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00394966
Start Date
September 1 2006
End Date
March 1 2008
Last Update
October 23 2009
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