PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

August 13, 2021

Study Completion Date

February 24, 2025

Conditions
Small Cell Lung CancerExtra-Pulmonary Small Cell Carcinomas
Interventions
DRUG

PLX038

Phase I: Dose escalation will follow the classical 3+3 trial design by Fibonacci sequence. Phase II: Maximum tolerated dose (MTD) identified in phase I. PLX038 (PEGylated SN38) will be administered as a 1 hour (-10 minutes / +30 minutes) intravenous (IV) infusion on Day 1 of each cycle (21 days).

DRUG

Rucaparib

Phase I: Dose escalation will follow the classical 3+3 trial design by Fibonacci sequence. Phase II: Maximum tolerated dose (MTD) identified in phase I. Rucaparib will be given orally at designated dose twice a day on days 5 to 19 of every 21-day cycle.

DRUG

Ondansetron

Participants will be recommended to have 8 mg of ondansetron taken with a small meal or snack to prevent nausea and vomiting approximately 30 minutes prior to each dose of rucaparib.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT04209595 - PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers | Biotech Hunter | Biotech Hunter