ovarian-cancer-clinical-feasability

 

With patients of ovarian cancer as the target trial population, a clinical trial feasibility was performed. The clinical trial sites / investigators, who participated in this feasibility came mainly from India, Russia, Philippines, Vietnam, Thailand and South Korea.

Clinical Trial Details

  • Patient population included Ovarian cancer patients, whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with Doxorubicin pegylated liposome intravenous injection
  • Patients who have a prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/ m2 or more after four cycles of treatment were excluded.
  • Trial design could be tailored without significant changes to meet USFDA guidance on Doxorubicin Liposome Injection In Vivo Bioequivalence Study.
  • While, the trial design suits USFDA submission requirements more closely, it could be utilized to target European / Thailand / India / other asian countries with suitable modifications.

Feasibility Results

While, clinical trial feasibility was primarily assessed with sites / investigators from India, an attempt was made to get feedback from sites / investigators from other potentially capable regions / countries. Here are the results of this feasibility.

Country

Average Recruitment Rate Per Site Per Month

India

>3

Philippines

4

Thailand

1

Vietnam

4

South Korea

2

Russia

4

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