Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 9, 2016

Primary Completion Date

April 19, 2023

Study Completion Date

March 4, 2025

Conditions
Urothelial CarcinomaUrothelial CancerLung NeoplasmsSmall Cell Lung CancerProstate Cancer
Interventions
DRUG

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)"

DRUG

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)."

DIAGNOSTIC_TEST

CT scan

Screening and baseline.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Bone scan

Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression.

DIAGNOSTIC_TEST

ECG

Screening, baseline, Day 1, Day 15 and cycle 2, Day 1.

DIAGNOSTIC_TEST

Echocardiogram

At screening.

PROCEDURE

Biopsy

Baseline Day 4 and end of treatment/disease progression.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02769962 - Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter