Chemotherapy Induced Nausea and Vomiting
Conditions
Interventions
Product Name: NK 1 Receptor Antagonist - Rolapitant
Product Code: SCH 619734
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Sponsors
Schering-Plough Research Institute, a division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that administration of SCH 619734 with ondansetron and dexamethasone improve CINV in the combined acute and delayed phase (0-120 hours), compared with the administration of placebo with ondansetron and dexamethasone alone in subjects receiving HEC.; Secondary Objective: 1. Determine the effect of SCH 619734 on complete response rate in the acute- (0 to 24 hrs) and delayed (> 24 to 120 hrs) phase of CINV. 2. Determine the effect of SCH 619734 treatment on the incidence of no emesis, no nausea, no significant nausea, total control, and complete protection in the acute, delayed, & combined phase of CINV, as well as determine time to emesis or to rescue medication. 3. Evaluate the effect of SCH 619734 treatment on quality of life, as assessed by the Functional Living Index Emesis Questionnaire (FLIE). The secondary safety objective of this study is to determine if SCH 619734 is safe and well-tolerated in patients receiving HEC. ; Primary end point(s): The primary efficacy endpoint for this study is the overall complete response rate (no emesis and no use of rescue medication 0 through 120 hours following initiation of cisplatin-based chemotherapy). The key secondary endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV. Other secondary endpoints for this study include - No emesis (no vomiting, retching, or dry heaves; includes subjects who received rescue medication): overall, acute, and delayed phases of CINV. - No nausea (maximum visual analog score (VAS) <5 mm): overall, acute, and delayed phases of CINV. - No significant nausea (maximum VAS <25 mm): overall, acute, and delayed phases of CINV -Time to first emesis or to rescue medication. - Total control (no emesis, no rescu | — |
Countries
Czech Republic
Outcome results
None listed