A Phase II, 2-stage Trial of CRLX101-202 in Recurrent Ovarian, Tubal and Peritoneal Cancer
You will receive CRLX101 through an intravenous (IV) infusion over an hour once every 14
days. You will receive the study drug on days 1 and 15 of each cycle. Each cycle is 28 days.
You will continue to receive CRLX101 until you and/or the research doctor decides it may
not be in your best interest to continue.
You will receive premedication including decadron, zantac and benadryl to help prevent an
allergic reaction and nausea prior to your CRLX101 infusion.You will also receive IV fluid
before and after the study drug administration to keep you hydrated. It will be important
for you to drink water regularly in between study visits.You will be treated as an
outpatient. At every clinic visit, you will undergo the following assessments: Medical
history, physical examination, vital signs, performance status, routine blood tests,
assessment for any new side effects, CT evaluation (every 8 weeks).
You will have an end of study visit within 30 days of your last dose.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
Progression free survival at 6 months (PFS6) using RECIST 1.1
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|