About the PRECEDENT Study:
The PRECEDENT study is a “combination” research study of Doxil® (pegylated liposomal doxorubicin) and EC145. Doxil® is approved for sale in the United States and is part of a standard treatment for patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy. The experimental drug, EC145, will be given to some study participants in combination with Doxil®. Other participants will only receive Doxil®.
The purpose of this study is to test the effects of EC145 in combination with Doxil®, good or bad, on platinum-resistant ovarian cancer. The study will also test the safety of EC145 in combination with Doxil®. Roughly 120 people are expected to participate in the study.
Participants in the study will be randomly assigned to one of two groups. This means that neither the participant nor the study physician can choose in which group the participant will be assigned. One out of three participants will be assigned to a group that will receive only Doxil®, the approved drug. This is considered the standard therapy typical of what many women not participating in a research study would receive. The other participants (two out of three) will be assigned to a group that will receive EC145, the investigational drug, in addition to Doxil®.
PRECEDENT Study schedule:
- Participants who receive Doxil® alone will receive a single infusion of drug once per month and will visit the study doctor’s office every other week for routine monitoring and tests.
- Participants who receive both Doxil® and EC145 will receive Doxil® (as above) in addition to short intravenous infusions of EC145 (lasting roughly 10 - 20 seconds) administered in the study doctor’s office three days per week (M·W·F) every other week.
- It is expected that participation in the study will last six weeks, but may be longer if continued benefit is observed.
Pre study scan:
Prior to starting study treatment with EC145, participants may have a nuclear medicine scan (which is like taking a picture) using an investigational imaging drug (a drug that shows up in a scan) called Technetium 99M EC20. This image allows the study doctor to see the cells we believe are more likely to “grab” EC145. This procedure has been performed in approximately 250 individuals (with and without cancer) and has been found to be well tolerated.
Common questions and answers:
Do study participants receive a placebo?
This study is designed so that every participant receives the approved standard therapy Doxil®. Approximately 2 out of 3 participants will receive EC145 in combination with Doxil®. No participants will receive a placebo.
Do participants pay any out-of-pocket costs?
Your health plan/insurance will be billed for all of the tests and procedures performed as standard care (tests that would be performed as part of regular medical care). There will be no charge for participation in this study, including study-specific tests and procedures. The study medication (EC145) will be provided at no charge.
Are there side effects of the study drugs?
As with any experimental drug, it is not always possible to predict all of the potential risks (things that may go wrong). There are common side effects associated with both Doxil® and the experimental drug (EC145). Prior to electing to participate in the study, participants should review with their study doctor the potential risks and benefits associated with the study.