A PHASE III, RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH ACTIVE COMPARATOR, PARALLEL GROUP, STUDYREALIZED IN CONDITIONS OF INTERNAL BLIND, TO EXAMINE THE SECURITY, TOLERABILITY AND EFFICACY OF A UNIQUE DOSE OF MK-0517 INTRAVENOUS FOR THE PREVENTION OF NAUSEA AND VOMITES INDUCED BY CHEMOTHERAPY (CINV) ASSOCIATED WITH CHEMOTHERAPY WITH CISPLATINO.
- Conditions
- -R11 Nausea and vomitingNausea and vomitingR11
- Registration Number
- PER-114-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient is male or female, and is> 18 years of age.
• The patient is scheduled to receive his first cycle of cisplatin chemotherapy for a documented solid malignancy at a dose of> 70 mg / m2.
• The patient is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
• The patient has a life expectancy of> 3 months.
• The patient has a Karnofsky score> 60 (see Appendix 6.2).
• Premenopausal patients must demonstrate a negative result in the urine pregnancy test (according to kits provided by the central laboratory) at the pre-study visit, and accept the use of a double-barrier contraceptive method for a minimum of 14 days before the last dose of the study drug, during the entire study drug administration, and for a minimum of 1 month after the last dose of the study drug. If the urine pregnancy test is negative, then the patient can be enrolled. However, if the urine pregnancy test is positive, the patient can only be enrolled if a subsequent serum pregnancy test is negative. Women who take oral contraceptives must agree to additionally use a barrier method of contraception. Abstinence is also considered an acceptable contraceptive method. If abstinence is not accepted locally. two acceptable contraceptive methods must be used. (Note: A patient who is not potentially fertile is eligible without the requirement of a contraceptive.The female patient is called a woman who is not potentially fertile, either: 1) she has reached menopause naturally ( what is defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea); 2) 6 weeks after a bilateral surgical oophorectomy with or without hysterectomy; or 3) bilateral tubal ligation.
• The patient can read, understand and fill out the diary and the study questionnaires
• The patient suffers from a malignancy of the primary CNS or symptomatic metastatic disease.
• The patient has received or will receive radiation therapy in the abdomen or pelvis in the week prior to the period from Day 1 to Day 6 of the Treatment.
• The patient has vomited within 24 hours prior to Day 1 of Treatment.
• The patient has an active infection (eg, pneumonia) or any uncontrolled disease (eg, diabetic ketoacidosis, preexisting gastrointestinal conditions / gastrointestinal obstruction) except for a malignancy or a history of any disease that. in the opinion of the investigator, it could confuse the results of the study or represent an unjustified risk when administering the study drug to the patient.
• The patient currently uses any illicit drug, including marijuana, or presents current evidence of alcohol abuse (defined using the DSM-IV criteria). according to the investigator´s determination.
• The patient is mentally disabled or suffers from a significant emotional or psychiatric disorder that. In the opinion of the researcher, it prevents his entry into the study.
• The patient will receive rescue therapy with stem cells along with the cisplatin chemotherapy cycle.
• The patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone
• The patient is pregnant or breastfeeding (potentially fertile patients are required to show a negative pregnancy test before entering the study, see inclusion criteria 6).
• The patient has participated in a study with aprepitant or has taken an unapproved (investigational) drug within the last 4 weeks.
• The patient will receive chemotherapy for several days with cisplatin in a single cycle.
• The patient will receive moderate or high emetogenicity chemotherapy (according to the Hesketh Classification of the Emetogenic Chemotherapy Agents, Appendix 6.3) for 6 days before the cisplatin infusion and / or for 6 days after the infusion of cisplatin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method