None listed
Conditions
Interventions
Group 1 Type of group
DAY 1
- 1 hour prior to cisplatin: Placebo of GW679769, Placebo of Aprepiant
- 30 minutes before cisplatin: Dexamethasone 20 mg, Ondasentron HCL 32 mg IV
DAY 2
- Morning: Placebo of GW679769, Placebo of Aprepiant and Dexamethasone 8 mg
- Night: Dexamethasone 8 mg.
DAY 3
- Morning: Placebo of GW679769, Placebo de Aprepiant and Dexamethasone 8 mg
- Night: Dexamethasone 8 mg.
DAY 4
- Morning: Dexamethasone 8 mg.
- Night: Dexamethasone 8 mg.
Group name:Group 6 Typ
DAY 1
- 1 hour prior to cisplatin: Placebo of GW679769, 125 mg of Aprepiant
- 30 minutes before cisplatin: Dexamethasone 12 mg, Ondasentron HCL 32 mg IV
DAY 2
- Morning: Placebo of GW679769, 80 mg of Aprepiant and Dexamethasone 8 mg
- Night: Dexamethasone placebo
DAY 3
- Morning: Placebo of GW679769, 80 mg of Aprepiant and Dexamethasone 8 mg
- Night: Dexamethasone placebo
DAY 4
- Morning: Dexamethasone 8 mg
- Night: Dexamethasone placebo
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: - Male or female with an age in less than 18 years. - Diagnosis of a solid malignant tumor and being programmed to receive the first course of chemotherapy with cysplatin a single dose> 70 mg / m on Day 1 of the study, as a single agent or in combination with other chemotherapeutic agents. - A score on the Kamofsky Scale for Performance in at least 70 - Adequate hematological and metabolic condition to receive chemotherapy with cisplatin - Ability and willingness to complete the Visual Analog Scales - Without potential to have a family or in premenopausal women, who show a negative result in tests to diagnose pregnancy in serum or urine within 24 hours prior to the first administration of any medication in the study or the product under investigation. - Understand the nature and purpose of the study and its procedures and sign an informed consent form
Exclusion criteria
Exclusion criteria: - Have previously received cytotoxic chemotherapy. - Be scheduled to receive more than 1 day of treatment with cisplatin during an isolated course of therapy. - Be programmed to receive adjuvant chemotherapy with regimens containing cyclophosphamide. - Pregnant woman or breastfeeding. - That the male subject does not want to use a condom with spermicide in addition to his female partner using another form of contraception. - Having received radiation therapy in the abdomen or pelvis within 7 days prior to receiving the first dose of study medication or investigational product and / or receiving radiation therapy in the abdomen or the abdomen. pelvis within 6 days after administering the first dose of study medication or investigational product. - Experienced emesis in the 24 hours prior to receiving the first dose of study medication or investigational product. - Clinically significant nausea in the 24 hours prior to receiving the first dose of study medication or product under investigation. - Have a known primary or metastatic malignancy in the central nervous system, unless it has been successfully treated and has remained stable for at least 1 week before receiving the first dose of study medication or product under investigation. - Have an etiology for emesis and nausea. - Have a known history of peptic ulcer disease or irritable bowel disease. - Have an active systemic infection or any uncontrolled disease. - Have begun a therapy with systemic corticosteroids in any dose within 72 hours before receiving the first dose of study medication or product under investigation. - Be programmed to undergo a bone marrow transplant or a rescue therapy with progenitor cells. - Having a known hypersensitivity or contraindication to ondansetron hydrochloride or ondansetron, to another 5-HT3 receptor antagonist, to dexamethasone, or to any component of GW679769. - Have previously received an antagonist of NK-1 receptors. - Have been treated with any investigational drug within 30 days or five half-lives (whichever is longer) prior to receiving the first dose of the study medication or product under investigation. - Have received a moderate and / or highly emetogenic medication within 48 hours prior to administering the first dose of study medication or product under investigation. - Having taken / received palonosetron within 7 days prior to administering the initial dose of study medication / investigational product. - Having taken / received any medication with potential or known antiemetic activity within the 24-hour period prior to receiving the study drug. - Having taken / received potent or moderate inhibitors of the CYP3A4 and CYP3A5 systems. - Having taken / received inducers of the CYP3A4 system within 14 days prior to administering the first dose of study medication or product under investigation. - Having abnormal values ​​in ASAT and / or ALAT laboratory tests> 2.5 times the upper limit of normality without known liver metastases, or> 5.0 times the upper limit of normality with liver metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: The complete response is defined as absence of vomiting, absence of retching, no use of rescue therapy and no premature discontinuation of participation in the study. Measure:Poportion of subjects who achieved complete response Timepoints:120 hours after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Analogue visual scale (VAS). Measure:Magnitude of experienced nausea. Timepoints:120 hours after giving your first cycle of chemotherapy. ; Outcome name:Routine physical examination, vital signs. Clinical laboratory tests: Complete hematological count, urea nitrogen, creatinine, electrolytes, ALT, AST, total bilirubin, albumin, total proteins, glucose and triglycerides. Report of adverse events. Measure:Safety of the treatment. Timepoints:Routine physical examination, vital signs: Before treatment, day 1 of each cycle of chemotherapy, visits from days 6 - 10. Clinical laboratory tests: Before treatment, day 1 of each cycle of chemotherapy, visits from days 6 - 10, 12-17 and 20-30. Report of adverse events: Day 1, day 1 of each subsequent cycle and visits from days 6 - 10, 12-17 and 20-30. | — |
Countries
Austria, Czech Republic, Hungary, Italy, Peru, Slovakia
Outcome results
None listed