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Title An Open-Label Randomized Active-Controlled Phase II Clinical Study to Assess the Efficacy and Safety of Afuresertib Plus Paclitaxel Versus Paclitaxel in Patients with Platinum-Resistant Ovarian Cancer
Therapeutic Area Ovarian Cancer
Principal Investigator John Schorge, MD
Min Age 18 Years
Gender Female
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To evaluate the clinical efficacy of afuresertib plus weekly paclitaxel versus weekly paclitaxel in patients with platinum-resistant ovarian cancer. 

Study Details

Inclusion Criteria

  1. Must not have previously received prior AKT or PI3K pathway or mTOR inhibitors.
  2. 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.
  3. 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

  1. Platinum-refractory disease (progression during or less than 1 month of receiving previous platinum-containing therapy)
  2. 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.
  3. 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