Veliparib (ABT-888), an Oral PARP Inhibitor, and VX-970, an ATR Inhibitor, in Combination With Cisplatin in People With Refractory Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2021-12-31

Summary

Background:

The drug cisplatin treats certain cancers when given with other chemotherapy drugs. Researchers think combining cisplatin with 2 other drugs could block proteins that support cancer cell growth. The other drugs are ABT-888 (veliparib) and VX-970. They want to test if this drug combination slows the growth of cancer and is safe.

Objectives:

To test the safety and tolerability of VX-970 and veliparib combined with cisplatin in people with advanced refractory solid tumors. To determine the maximum tolerated dose of these drugs.

Eligibility:

People ages 18 and older with:

• Solid tumors that have progressed after treatment or for which no treatment exists

• Normal organ and marrow function

Design:

Participants will be screened with:

• Medical history

• Physical exam

• CT scan or MRI

• Blood and urine tests

Participants will get the study drugs in 3-week cycles:

• Cisplatin in a vein on 1 or 2 days

• VX-970 in a vein on 2 days

• Veliparib by mouth twice a day on 6 days

In each cycle, participants will have 5 physical exams and blood tests 5 times.

In some cycles, participants will have CT scans or MRIs.

In cycle 1, participants may have 2 tumor biopsies. A small piece of tissue is removed by needle.

Participants will keep a study diary. They will write when they take the drugs and if they have side effects.

Participants will stay in the study as long as they tolerate the drugs and their tumors are not getting worse.

Participants will have a phone call about a month after their last dose.

• Phase: Phase 1

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cisplatin; Poly(ADP-ribose) Polymerase Inhibitors; Veliparib