DOSE DETERMINATION STUDY, RANDOMIZED, DOUBLE BLIND OF PARALLEL CONTROLLED GROUPS WITH PLACEBO, CARRIED OUT UNDER INTERNAL BLIND CONDITIONS WHICH PURPOSE IS TO EXAMINE THE TOLERANCE AND EFFECTIVENESS SECURITY OF THE MK-0869 FOR THE PREVENTION OF ACUTE AND LATE THINGS ASSOCIATED WITH THE ADMINISTRATION OF HIGH DOSE OF CISPLATI

Not Applicable

• Conditions: -R11 Nausea and vomiting; Nausea and vomiting; R11

• Registration Number: PER-009-99
• Lead Sponsor: MERCK SHARP & DOHME PERÚ S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-09-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient is an adult with an age of> 18 years.
• The patient is expected to receive his first series of cisplatin chemotherapy for a histologically documented solid tumor at a dose of> 70 mg / m ^ 2 administered in <3 hours.
• Premenopausal patients must prove a negative pregnancy test with sensitivity of 25 IU in serum or urine at the Pre-Study Visit and agree to use an appropriate contraceptive method at least 14 days before, from the beginning to the end, and at least 14 days after the last dose of the study drug. Women taking oral contraceptive agents should agree to add a form of barrier contraception. Women who have gone through menopause or have had a hysterectomy or tubal ligation are exempt from this requirement. Postmenopause is defined as absence of menstruation during the previous year. If the cessation of menstruation is within 18 months, FSH should be documented as elevated postmenopausal in the pre-study.
• The patient has a Kamofsky score of> 60 (Appendix 1) and has an expected life expectancy of> 3 months.
• The patient is able to understand and complete the questionnaires and the study diary, including questions that require an answer according to the visual analog scale (VAS).
• The patient understands the procedures and agrees to participate in the study by providing written informed consent.

Exclusion Criteria

• The patient is mentally incapacitated or has an important emotional or psychiatric disorder that, in the opinion of the researcher, prevents his admission to the study.
• The patient currently uses illicit drugs or there is current evidence of alcohol consumption determined by the investigator.
• The patient is undergoing treatment for epilepsy.
• The patient has received an unauthorized drug in the last 4 weeks.
• Abnormal laboratory values
• The patient has a history of diseases that, in the opinion of the researcher, could confuse the results of the study or represent an unjustified risk when administering the study drug to the patient.
• The patient has an active infection (for example, pneumonia) or any uncontrolled disease (for example, diabetic ketoacidosis, gastrointestinal obstruction) except for a tumor that in the opinion of the investigator could confuse the results of the study or represent an unjustified risk when administering the Study drug to the patient.
• The patient will receive a multi-day chemotherapy with cisplatin in a single cycle.
• The patient will receive a chemotherapy of moderate or high emetogenicity (Hesketh Level 3 or higher; Appendix 2) on the day (s) before and / or after the day the cisplatin infusion is performed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified