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.
Single group
Niraparib Tosylate Monohydrate
DrugCombination of niraparib and abemaciclib
dose finding
This is a dose-escalation study of niraparib plus abemaciclib followed by an efficacy study for late-line treatment of ovarian cancer
dose finding, phase Ib clinical trial
Maximum tolerated dose (MTD) of niraparib in combination with abemaciclib in patients with advanced ovarian cancer defined as the dose level immediately below the dose at which ≥ 33% of patients experience dose-limiting toxicity as defined by protocol according to CTCAE 5.0
PART II: Disease control rate at 16 weeks (DCR16wks):
proportion of patients whose disease shrinks (i.e. complete or partial response) or remains stable over 16 weeks after the start of niraparib + abemaciclib combination. Revised RECIST 1.1 criteria will be used to assess tumor response
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
GlaxoSmithKline
Collaborator
Eli Lilly and Company
Collaborator
