None listed
Conditions
Interventions
AZD5363: A twice daily regimen of an oral formulation given on an intermittent dosing schedule of 4 days of treatment followed by 3 days offtreatment: 200 mg bd (400 mg daily) each week that paclitaxe
but further cycles can be continued at an investigator’s
discretion based on the patient’s risk/benefit profile.
Target patient population
Part B. Randomised expansion: Female patients, 18 ye
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent provided 2. Female patients, aged at least 18 years 3. Histological or cytological confirmation of breast cancer 4. World Health Organisation (WHO) performance status 0-1 5. Patients must be able to swallow and retain oral medication. 6. Patients of child-bearing potential should use a contraceptive measures, should not be breast feeding and must have a negative pregnancy test or Patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal, Documentation of irreversible surgical sterilisation. 7. Patients must not be breast feeding. Part B. Randomised Expansion: 1. Patients with histological or cytologic diagnosis of ER+ve breast cancer with evidence of relapsed advanced or metastatic disease. 2. Patients who relapsed more than 12 months after completing adjuvant endocrine therapy, or who have not had adjuvant endocrine therapy, must have received prior endocrine therapy for advanced or metastatic disease. Patients who relapsed on adjuvant endocrine therapy, or within 12 months of completing adjuvant endocrine therapy, may enter the study without prior endocrine therapy for advanced or metastatic disease 3. Provision of archival tumour sample for PIK3CA mutation testing. 4. Provision of baseline plasma sample for PIK3CA mutation testing. 5. At least one tumour lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm.
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and/or conduct of the study 2. Previous enrolment in the present study. 3. Participation in another clinical study with an investigational product 4. Receipt of any investigational drug within 30 days or 5 half-lives 5. Exposure to agents that inhibit AKT 6. Exposure to agents with PI3K 7. Use of aromatase inhibitors 8. Exposure to potent inhibitors or inducers of CYP3A4 9. Clinically significant abnormalities of glucose metabolism 10. Radiotherapy within 4 weeks before the first dose of IP 11. Last dose of anticancer therapy within 21 days before the first dose of study treatment. 12. Major surgery within 4 weeks before the first dose of study treatment. 13. Spinal cord compression or brain metastases 14. Severe or uncontrolled systemic diseases 15. Cardiac criteria 16. Unresolved toxicities from prior therapy 17. Nutrophil count 2.5 times ULN 21. AST >2.5 times ULN 22. TB >1.5 times ULN 23. Creatinine >1.5 times ULN 24. Proteinuria >3+ 25. Sodium or potassium outside normal range 26. Refractory nausea and vomiting 27. History of hypersensitivity to AZD5363 or paclitaxel 28. Judgment by the Investigator 29. Current disease or condition known to interfere with metabolism of drugs 30. Chronic Pulmonary diseases 31. Psychiatric diseases 32. Allogeneic bone marrow transplant 33. Immunodeficiency syndrome 34. Blood transfusion
Countries
Bulgaria, France, Japan, Mexico, Peru, Spain, United Kindgdom
Contacts
Public ContactCarlos Alonso Arbulu
ASTRAZENECA PERU S.A.
Outcome results
None listed