None listed
Conditions
Interventions
Group 1 Type of group
Carboplatin / paclitaxel 6 cycles plus 175 mg of AZD0530 1 time a day and Maintenance 175 mg of AZD0530 1 time a day
Group name:Group 2 Type of group
carboplatin / paclitaxel 6 cycles plus placebo of AZD0530 1 time a day and placebo maintenance of AZD0530 1 time a day
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Signature of informed consent • Women aged 18 or over • Histological diagnosis of: Ovarian epithelial carcinoma, Carcinoma of the fallopian tubes, Primary serous peritoneal carcinoma • Advanced disease not eligible for surgery or curative radiotherapy at the time of inclusion in the study • Radiological signs of recurrence or progression of the disease at least 6 months after the cessation of a first or second line treatment containing platinum (including maintenance treatment based on platinum) • Unmeasurable or measurable lesion documented according to the RECIST criteria, assessed by computed tomography (CT) or magnetic resonance (MR). • Functional status from 0 to 2 according to the World Health Organization (QMS). • Estimated life expectancy of more than 12 weeks • Evidence of absence of fertility: negative pregnancy test in the 7 days before the study treatment in women of childbearing age, or postmenopausal state (defined by any of the following circumstances: natural menopause, with the last menstruation> 1 year before; radiation-induced oophorectomy, with the last menstruation> 1 year before, menopause induced by chemotherapy with an interval> 1 year since the last menstruation), or surgical sterilization (bilateral oophorectomy or hysterectomy) • Patients must meet the following criteria to be included in the optional pharmacogenetic research: Sign informed consent for genetic research
Exclusion criteria
Exclusion criteria: • Clinical evidence of metastasis in the central nervous system (CNS) • Non-epithelial ovarian cancer, including mullerian malignant mixed tumors and mucinous carcinoma of the peritoneum. • Tumor of borderline malignancy • A second primary malignant process (except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin) • Insufficient medullary reserve, demonstrated by an absolute neutrophil count 2 times the upper limit of the reference interval (LSIR), of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or ALP> 2.5 times the LSIR (AL?> 5 sometimes the LSIR if the researcher considers it related to liver metastases) • Patients with an estimated GFR 1 year before; radiation-induced oophorectomy, with the last menstruation> 1 year before; menopause induced by chemotherapy with an interval> 1 year from the last menstruation, or surgical sterilization (bilateral oophorectomy or hysterectomy) • Unresolved toxicity of grade> 2 of CTCAE due to previous anticancer treatment, except alopecia • Symptomatic peripheral neuropathy of grade> 11 of NCIC-CTC • Resting ECG with a measurable QTc interval> 480 msec at 2 or more time points within a 24-hour period • Current or previous use within the specified time period of drugs or herbal supplements that are known potent inducers or inhibitors of CYP3A4 • Known hypersensitivity to AZD0530, its excipients or drugs in your group • Impossibility of an adequate follow-up during the entire participation in the trial. • Participation in another trial with an investigational medication in the previous 90 days or participation in a previous clinical study within 30 days prior to entering the trial • Risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The RECIST will be used to determine the TRO (RC and RP) and the SLR. Baseline radiological assessments of the tumor should be made no more than 4 weeks before the start of treatment of trial, but at a time as close as possible to that start. Measure:Objective tumor response rate Timepoints:4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A blood sample (3 me) will be obtained for PK analysis of AZD0530 and M594347 before any dose of trial treatment at visit 2 and before cycles 3 and 5, and another sample more between 2 and 6 hours after a dose of AZD0530 in the assessments of cycles 3 and 5 Measure:Carboplatin AUC predicted from plasma platinum concentration for 24 hours Timepoints:At visit 2 and before cycles 3 and 5, and another sample more between 2 and 6 hours after a dose of AZD0530 in the assessments of cycles 3 and 5 ; Outcome name:The RECIST will be used to determine the TRO (RC and RP) and the SLR. Baseline radiological assessments of the tumor should be made no more than 4 weeks before the start of treatment of trial, but at a time as close as possible to that start. Measure:Time from randomization to progression of the disease according to the RECIST criteria, or death (for any cause in the absence of progression Timepoints:4 weeks ; Outcome name:The tumor size will be measured as the sum of the lengths of the largest diameters of the target lesions according to RECIST. Measure:Change in tumor size Timepoints:During the study ; Outcome name:Blood will be drawn for central analysis of CA-125. Venous blood samples (1 ml) will be collected for determination of CA-125 in serum at the moments indicated in the test plan Measure:Progression of the CA-125 Timepoints:During the study ; Outcome name:Determined by the abdominal scale, more individual elements related to ascites and intestinal obstruction (nausea, anorexia, vomiting, asthenia, dyspnea, heartburn), of the questionnaire QLQ-C30 + OV28 of the EORTC. Determined by the questionnaire QLQ-C30 + OV28 of the EORTC.- Measure:Results reported by patients (RCP) Timepoints:4 weeks ; Outcome name:A blood sample (3 me) will be obtained for PK analysis of AZD0530 and M594347 before any dose of trial treatment at visit 2 and before cycles 3 and 5, and another | — |
Countries
Bulgaria, Canada, Denmark, France, Netherlands, Norway, Peru, Portugal, Romania, Russian Federation, Spain, United Kindgdom
Contacts
Public ContactCarlos Seminario
ASTRAZENECA PERU S.A.
Outcome results
None listed