PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers
Status:
Suspended
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Background:
Drugs known as PARP inhibitors are known to help stop tumor growth in patients with breast,
ovarian cancers and many other cancers including prostate and pancreatic cancers. Many
research studies done in animals and human cells have shown that these type of drugs can
improve how well chemotherapy works. Standard chemotherapy can be too toxic to be combined
with PARP inhibitors. In this study, we use a new form of chemotherapy called PLX038 to see
if it can be safely combined with PARP inhibitors to shrink tumors.
Objective:
To find a safe combination of PLX038 and rucaparib, and to see if this mix will cause tumors
to shrink.
Eligibility:
People age 18 and older with solid tumors, SCLC, or small cell cancer outside their lungs.
Design:
Participants will be screened with:
Physical exam
Blood tests
Records of their diagnosis (or they will have a tumor biopsy)
A review of their symptoms and medications
A review of their ability to perform their normal activities
Electrocardiograms to measure the electrical activity of the heart
Computed tomography (CT) scans of the chest, abdomen, and pelvis. CT scans are a series of
X-rays.
Participants will get PLX038 by intravenous catheter on Day 1 of each cycle (1 cycle = 21
days). For this, a small plastic tube is put into an arm vein. They will take rucaparib twice
daily by mouth on Days 3 to 19 of each cycle. They will keep a medicine diary.
Participants may give a hair sample. They may have optional tumor biopsies.
Screening tests are repeated throughout the study.
About 30 days after treatment ends, participants will have a safety follow-up visit. They
will give blood samples, talk about their health, and get a physical exam. Then they will be
called or emailed every 6 months....