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)
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Registration Number
- EUCTR2005-004712-73-CZ
- Lead Sponsor
- Schering-Plough Research Institute, a division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
1. Subject is equal to or older than 18 years of age.
2. Subject has never been treated with cisplatin in the past and is to receive first course of cisplatin-based chemotherapy (=70 mg/m2).
3. Subject has a Karnofsky performance score of greater than or equal to 60.
4. Subject has a predicted life expectancy of greater than or equal to 3 months.
5. Subject has adequate bone marrow, kidney and liver functions, as evidenced by.
a. Absolute neutrophil count greater than or equal to 1,500/mm3 and WBC count greater than or equal to 3,000/mm3.
b. Platelet count greater than or equal to 100,000/mm3.
c. AST less than or equal to 2.5 x upper limit of normal range.
d. ALT less than or equal to 2.5 x upper limit of normal range.
e. Bilirubin less than or equal to 1.5 x upper limit of normal range, except for subjects with Gilbert syndrome.
f. Creatinine less than or equal to 1.5 x upper limit of normal range.
If a single or multiple laboratory test value exceeds, but is close to, the limit(s) of the reference range(s) as defined in the protocol, subjects will be allowed to repeat these out –of-range tests once. If the repeated test results meet the study requirement, these subjects can be enrolled.
6. Female subjects of childbearing potential must agree to use a physical method of contraception. Female subjects who are postmenopausal (ie, have amenorrhea for 12 months) or surgically sterile are exempted from the use of contraception during the study.
7. Subject is able to read, understand, and complete the FLIE Questionnaire, SPNVHSU Scale, SPNVWAPI Questionnaire, SPNV Subject Diary, SPNVQOL Scale, and other study-related documents.
8. Subject provides written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any current treatment or medical history (eg, subject is mentally incapacitated, 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.
2. Subject has a 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.
3. Subject is a woman of childbearing potential with a positive urine pregnancy test 3 days prior to study drug administration.
4. Subject has previously received cisplatin.
5. Subject has participated in a clinical trial receiving the last dose of the investigational agent within 30 days prior to the start of administration of study drug.
6. Subject has taken the following agents within the last 5 days prior to the start of treatment with study drug until Day 6 of the study unless these agents are used as rescue medication or as part of the study treatment:
a. 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc)
b. Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc)
c. Antipsychotics (haloperidol, droperidol, olanzepin, etc)
d. Benzamides (metoclopramide, alizapride, etc)
e. Domperidone
f. Cannabinoids
g. NK1 antagonist (aprepitant)
h. benzodiazepines
i. Antihistamines (dimenhyinate, diphenylhyramine, etc)
j. Excessive alcohol consumption (ie, more than two drinks per day)
7. 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. There is no restriction for Day 1.
8. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
9. Subject has received systemic corticosteroid therapy within 72 hours of Day 1 of the study, except as premedication for chemotherapy. The subjects who are receiving chronic daily steroid therapy can be enrolled provided that the daily steroid dose is less than or equal to 10 mg of prednisone or equivalent.
10. Subject who has symptomatic primary or metastatic CNS malignancy.
11. Subject who has ongoing vomiting caused by any organic etiology or has a history of anticipatory nausea and vomiting.
12. Subject who is planning to receive chemotherapy on multiple days with cisplatin in a single cycle.
13. Subject who has vomited and/or has dry heaves/retching within 24 hours prior to the start of cisplatin infusion on Day 1 in Cycle 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method