This is an interventional trial. The goal of this clinical trial is dose finding. There are two phases: phase Ib to determine the MTD and recommended phase II dose of niraparib in combination with abemaciclib in patients with advanced ovarian cancer.
Target population will be patients (woman, age \> 18 years) with epithelial ovarian, fallopian tube or peritoneal cancer treated with at least 2 lines of therapy.
Has read and understands the informed consent form and has given written informed consent prior to any study procedures.
Age > 18 years
Life expectancy of at least 3 months
Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer
Any other prior therapy directed at the malignant tumor, including immunologic agents administered within 4 weeks prior to first dose of study drug
Major surgical procedures ≤ 28 days of beginning study treatment, or minor surgical procedures < 7 days. No timeline window required for port-a-cath placement.
Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
History of any ≥ grade 3 hematological toxicity due to prior chemotherapy that persisted for more than 4 weeks.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
GlaxoSmithKline
Collaborator
Eli Lilly and Company
Collaborator