A MULTICENTER STUDY, IN PHASE II, RANDOMIZED, DOUBLE-BLINDED, IN PARALLEL GROUPS, CONTROLLED WITH PLACEBO AND WITH AN ACTIVE SUBSTANCE, TO ESTABLISH THE DOSE, ON THE SAFETY AND EFFICACY OF THE ORAL ANTAGONIST OF RECEPTORS FOR NEUROKININ-1, GW679769, WHEN ADMINISTERED AT 50 MG, 100 MG AND 150 MG DAIRY DOSES IN ORAL TABLETS IN COMBINATION WITH ONDANSETRON CHLORHYDRATE AND DEXAMETHASONE FOR THE PREVENTION OF NAUSEA AND VOMITING INDUCED BY CHEMOTHERAPY IN SUBJECTS WITH CANCER WHO RECEIVE A HIGHLY EMETOGENIC CHEMOTHERAPY BASED ON CISPLATI
- Conditions
- -R11 Nausea and vomitingNausea and vomitingR11
- Registration Number
- PER-003-05
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method