45
Participants
Start Date
May 9, 2016
Primary Completion Date
April 19, 2023
Study Completion Date
March 4, 2025
EP0057
"EP0057 (formerly CRLX101) intravenous (IV) every (Q) 2weeks Day 1 and Day 15, administered in 28-day cycles, until disease progression or development of intolerable side effects.~Plus olaparib (by mouth (PO) days 3-13\* and days 17-26\*) administered in 28-day cycles, until disease progression or development of intolerable side effects. Phase (P)1: Dose Escalation P2: recommended phase 2 dose (RP2D).~(\* On days 13 and 26, only one dose of olaparib will be administered in the morning)"
olaparib
"Olaparib (by mouth (PO) days 3-13\* and days 17-26\* administered in 28-day cycles, until disease progression or development of intolerable side effects Plus EP0057 (formerly CRLX101) (intravenous (IV) every (Q) 2 weeks, Day 1 and Day 15) administered in 28-day cycles, until disease progression or development of intolerable side effects. Phase (P)1: Dose Escalation P2: recommended phase 2 dose (RP2D).~(\* On days 13 and 26, only one dose of olaparib will be administered in the morning)."
CT scan
Screening and baseline.
CT chest, abdomen, and pelvis
Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression.
Bone scan
Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression.
ECG
Screening, baseline, Day 1, Day 15 and cycle 2, Day 1.
Echocardiogram
At screening.
Biopsy
Baseline Day 4 and end of treatment/disease progression.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH