Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

Not Applicable

Completed

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

• Registration Number: PER-076-06
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. The subject understands the nature and purpose of this study and its procedures, and has signed an informed consent form to indicate it.
2. You are at least 18 years of age.
3. You have been scheduled to receive your first cycle of a moderately emetogenic chemotherapy regimen containing anthracycline and cyclophosphamide for the treatment of a malignant solid tumor.
4. Has an ECOG performance status of 0, 1, or 2.
5. The hematological and metabolic status must be adequate to receive a moderately emetogenic regimen and must meet the following criteria: a) Total Neutrophils ≥ 1500 / mm3. b) Platelets ≥ 100,000 / mm3. c) Bilirubin ≤ 1.5 x ULN. d) Liver enzymes should be below the following normal limits.
6. The subject is willing and able to complete daily the components of the subject´s diary for each cycle of the study.
7. Women of reproductive age should commit to the consistent and correct use of an acceptable method of birth control.

Exclusion Criteria

1. Patient has previously received cytotoxic chemotherapy.
2. It is a female subject who is pregnant or breastfeeding.
3. Patient has received radiation therapy in the brain, abdomen or pelvis during the ten days prior to the first dose of study medication and / or will receive radiation therapy in the brain, abdomen or pelvis for six days after the first dose of the study medication.
4. Patient is scheduled to receive therapy with taxanes during cycle 1.
5. You have experienced clinically significant emesis or nausea during the 24 hours before the first dose of the study medication.
6. It has a known primary or metastatic malignancy in the central nervous system.
7. Has a documented history of peptic ulcer, active peptic ulcer, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition that may confuse the results of the study, represent another potential etiology for emesis and nausea, or pose an unwarranted risk for the subject.
8. Presents hypersensitivity or a known contraindication to ZOFRAN, to another 5-HT3 antagonist receptor, to dexamethasone or to any component of casopitant.
9. Previously, he has received an antagonist receptor for NK-1.
10. Received a research drug during the previous 30 days or is scheduled to receive a research drug other than casopitant during the study period.
11. Took / received any medication with moderately or highly emetogenic potential within 48 hours prior to the first dose of the study medication.
12. Took / received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving the study medication.
13. Took / received strong or moderate inhibitors of CYP3A4 and CYP3A5 during a specific period prior to the administration of the investigational product.
14. Took / received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of the investigational product.
15. You are taking the antidiabetic agent repaglinide or the diuretic torasemide.
16. You are currently taking or considering taking any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified