Full TitleA Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD6738 in Combination with Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients with Advanced Solid Malignancies (Version 7 Date: 22-JUN-2016)
This is a phase I study of ascending doses of AZD6738 given in combination with chemotherapy regimens and/or novel anticancer agents to patients with advanced malignancies. The initial combination to be investigated is AZD6738 with carboplatin. The second combination to be evaluated is AZD6738 with olaparib. The third combination to be assessed is AZD6738 with MEDI4736.
AZD6738 and olaparib are given orally (by mouth), and carboplatin and MEDI4736 are given intravenously (by vein).
To be eligible for this study, patients must:
- Have advanced cancer that cannot be treated with standard therapy.
- Have an ECOG status of 0 or 1.
- Be age 18 or older.
- The expansion phases of the study will include patients having second-line treatment for ATM-deficient lung adenocarcinoma; those with ATM-deficient advanced gastric adenocarcinoma and no prior PARP inhibitor treatment; and patients with advanced recurrent or metastatic non-small cell lung cancer or head and neck squamous cell carcinoma.