AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer OVERT-1
- Conditions
- -C56 Malignant neoplasm of ovaryMalignant neoplasm of ovaryC56
- Registration Number
- PER-044-08
- Lead Sponsor
- ASTRAZENECA - PERU,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• 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
• 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 <1.5 X 10 9/1 or by a platelet count <100 x 10 9 / l.
• Hemoglobin <9 g / dl (5.59 mmol / L).
• Inadequate liver function, demonstrated by bilirubin values> 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 • Last dose of cancer treatment received in the 14 days prior to the first dose of treatment with the trial drug. If a sufficient elimination time has not elapsed due to the scheme or PK properties, a longer elimination period will be required according to the expected time of the antitumor effect or the known duration and the time to the reversibility of the AAs related to the drug, according to AstraZeneca and the researcher.
• Have received more than 2 previous chemotherapy regimens for ovarian cancer treatment
• Evidence of uncontrolled systemic processes (eg, severe hepatic dysfunction, interstitial lung disease [bilateral diffuse parenchymal lung disease]) or current unstable or decompensated respiratory or cardiac processes that make it undesirable for the patient to participate in the trial or may put compromising compliance with the protocol.
• Any other simultaneous process that, in the opinion of the researcher, discourages the participation of the patient in the trial or may endanger compliance with the protocol.
• Pregnant or lactating women
• Lack of willingness to use an acceptable contraceptive method during the study stay (in women of childbearing age) and in the three months following the cessation of administration of AZD0530 / placebo equivalent. The postmenopausal status will be considered sufficient proof that the patient is not of childbearing age and is defined as any of the following situations: 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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method