A Phase I/II Study of MEDI4736 in Combination with Olaparib in Patients with Advanced Solid Tumors. - MEDIOLA

Exclusion Criteria

• • Prior chemotherapy or other systemic anticancer therapy within 4 weeks prior to start of olaparib treatment, 6 weeks for nitrosoureas or mitomycin. Exceptions include: Anti-hormonal treatment for ER positive or PR positive breast cancer is allowed until 7 days prior to treatment with olaparib, exposure to an investigational agent within 30 days or 5 half-lives (whichever is the longer) prior to start of olaparib treatment is not allowed, prior receipt of biologics targeting T cell co-regulatory proteins and/or immune checkpoints is not allowed. Examples include MEDI4736 or other PD1 or PD-L1 or PD-L2 inhibitors or anti-CTLA4 therapy, previous treatment with a PARP inhibitor, is not allowed.
• • Radiation therapy within 4 weeks prior to start of olaparib treatment (includes radiation targeting bone metastases) or radionuclide treatment within 6 weeks of treatment start.
• • Current dependency on total parenteral nutrition or IV fluid hydration.
• • Concomitant use of known strong cytochrome P450 (CYP) 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. Concomitant use of known strong or moderate CYP3A inducers.
• • Concomitant therapy with any other anticancer therapy or chronic use of systemic corticosteroids.
• • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
• • Whole blood transfusions in the last 120 days
• •Patients with symptomatic or uncontrolled brain metastases.
• • Patients being considered at poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease.
• • Any psychiatric disorder that prohibits obtaining informed consent
• • Major surgery or significant traumatic injury within 2 weeks of run-in
• • Immunocompromised patients
• • QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment
• • Pregnant and breastfeeding women are excluded.
• • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• • Previous enrolment in the present study
• • Participation in a clinical study within 28 days or 5 half-lives of the drug, whichever is longer.