Clinical Trials

Title   AstraZeneca Solo3
Principal Investigator/ Physician   Jennifer Scalici, MD
Protocol┬áNo.   Solo 3
Open Date   03/01/2015
Gender   Female
Cancer Site   Ovarian
Status   Open
Sponsor   Astra Zeneca
Contact Email   MCI Clinical Trials

Protocol Title:  "A Phase III, Open Label, Randomized, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician’s Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients carrying germline BRCA1/2 Mutations."

Inclusion Criteria:  Patients must be >18 years of age, Female patients with histologically diagnosed relapsed high grade serous ovarian cancer or high grade endometroid cancer, Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious, At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment, Patients must have received at least 2 previous lines of chemotherapy for ovarian cancer randomization, Patients must be partially platinum sensitive or platinum sensitive, patients must have a life expectancy >16 weeks.

Exclusion Criteria: BRCA 1 and/or BRCA2 mutations that are considered to be non-detrimental, Exposure to an investigational product within 30 days, Any previous treatment with a PARP inhibitor including olaparib, Patients who have platinum resistant or refractory disease defined as progression during or within 6 months of the last platinum based chemotherapy, Patients receiving any systemic chemotherapy within 3 weeks prior to start of study treatment or radiotherapy within 2 weeks prior to start of study treatment, Patients with myelodysplastic syndrome/treatment related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML, Patients with symptomatic uncontrolled brain metastases, Major surgery within 2 weeks of starting study treatment, Patients unable to swallow orally administered medication and patients with gastrointestinal disorders, Breast feeding women, Patients with known active hepatitis B or C or HIV, Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation.

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