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NCT02723864 · ClinicalTrials.gov registry record · Phase 1
Veliparib (ABT-888), an Oral PARP Inhibitor, and VX-970, an ATR Inhibitor, in Combination With Cisplatin in People With Refractory Solid Tumors
A Phase 1 study of Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 3
- Study locations
NCT02723864: Completed Phase 1 study of Neoplasms, sponsored by National Cancer Institute (NCI).
NCT02723864 is a Phase 1 study of Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02723864, a Phase 1 study of Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 3
- Study locations
Study 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 M6620 (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 * Computed tomography (CT) scan or magnetic resonance imaging (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.
Primary Outcome
Adverse events were assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life threatening, and Grade 4 is life threatening.
Conditions Studied
Interventions
- DRUG Veliparib + VX-970 + Cisplatin
Study Locations (3)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Massachusetts
- Dana Farber Cancer Institute - Boston
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-08-09 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 1 |
What the finished NCT02723864 record still lists
NCT02723864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Veliparib + VX-970 + Cisplatin is the first listed.
NCT02723864 reports a single indexed study location in Maryland, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT02723864 about?
NCT02723864 is a clinical study titled "Veliparib (ABT-888), an Oral PARP Inhibitor, and VX-970, an ATR Inhibitor, in Combination With Cisplatin in People With Refractory Solid Tumors". 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 M6620 (VX-970). They want to test if this drug c...
What is the current status of trial NCT02723864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2017-08-09. Estimated completion is 2021-12-31.
What conditions does trial NCT02723864 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT02723864?
The interventions under investigation include: Veliparib + VX-970 + Cisplatin (DRUG).
Who is sponsoring clinical trial NCT02723864?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02723864 being conducted?
This trial has 3 study locations across Maryland, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02723864's enrollment target sits among peer trials
53 103rd of 158 higher than 55 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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