To evaluate the clinical efficacy of afuresertib plus weekly paclitaxel versus weekly paclitaxel in patients with platinum-resistant ovarian cancer.
Inclusion Criteria
- Must not have previously received prior AKT or PI3K pathway or mTOR inhibitors.
- Must have platinum-resistant ovarian cancer (including fallopian tube and primary peritoneal carcinoma), as defined as cancer progression between 1 month and 6 months after completion of prior platinum-based therapy (at least 4 cycles). Progression is defined by RECIST 1.1 criteria in association with symptoms necessitating treatment.
- The ovarian cancer patients must have received 1 to 3 prior platinum-based regimens before platinum-resistant ovarian cancer was diagnosed. No other additional anticancer treatment is allowed except for PARP inhibitor or bevacizumab
Exclusion Criteria
- Platinum-refractory disease (progression during or less than 1 month of receiving previous platinum-containing therapy)
- HIV-positive patients with 1 or more of the following: not receiving highly active antiretroviral therapy, receiving antiretroviral therapy that may interfere with the study drug, CD4 count < 350 based on a test within 3 months of the screening visit, or an acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of screening.
- Prior receipt of chemotheraepy, PARP inhibitor, bevacizumab, or investigational therapy within 28 days of enrollment or within 5 half-lives of the agent, whichever is shorter.
Study Requirements
Number of research visits & Length of Participation: Patients to continue of study treatment until disease progression, severe noncompliance with protocol, withdrawal of consent, or if patient becomes pregnant. Each cycle will be 3 weeks and after end of treatment patients will be followed every 12 weeks for survival.
Number of blood collections:
-CBC to be tested every week for the first 2 cycles, then once per cycle (once every 3 weeks)
-Clinical chemistry at screnning, PK control, C2D1, D1 of subsequent cycles, EoT
-Coagulation, creatine clearance, fasting lipid panel, hemoglobin A1C, TSH at screening and weeks 13 and 28 and then every 12 weeks
-CA-125 at PK control and every 6 weeks for 20 weeks then every 8 weeks starting at D1 of C3 and onward
-Pharmacokinetics at PK control and D1 of every cycle
Number of X-rays/CT scans/MRIs: as standard of care
