A Phase Ib Study of OMP-54F28 with Paclitaxel and Carboplatin in Patients with Recurrent Platinum-Sensitive Ovarian Cancer

Protocol
14-029
Full Title
A Phase 1b Dose Escalation Study of Ipafricept (OMP-54F28) in Combination with Paclitaxel and Carboplatin in Patients with Recurrent Platinum-Sensitive Ovarian Cancer
Phase
I
Purpose

Paclitaxel and carboplatin are chemotherapy drugs commonly used to treat ovarian cancer. However, the cancer often returns. This may be because these cancer drugs do not target cancer stem cells. Cancer stem cells are thought to be involved in cancer spread and recurrence and are often resistant to traditional anticancer therapy.

OMP-54F28 is an investigational drug designed to block the growth of cancer stem cells. It may work particularly well when given with paclitaxel and carboplatin. In this study, researchers want to find the highest dose of OMP-54F28 that can be given safely with paclitaxel and carboplatin in women with ovarian, fallopian tube, or primary peritoneal cancer that initially responded to platinum-based therapy but then came back.

All three drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ovarian, fallopian tube, or primary peritoneal cancer that came back 6 months or more after completing platinum-based chemotherapy (platinum-sensitive cancer).
  • Patients may not have already received paclitaxel and carboplatin for recurrent disease.
  • At least 3 weeks must have passed since completion of prior anticancer therapy and entry into the study.
  • Patients may not have osteoporosis.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Disease(s)
Ovarian Cancer
Locations
Related Diseases