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NCT03061188 · ClinicalTrials.gov registry record · Phase 1
Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03061188: Completed Phase 1 study, sponsored by Northwestern University.
NCT03061188 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03061188, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the highest and safest dose of the experimental drug veliparib when combined with nivolumab. We will also study how safely this combination of medication can be given in advanced cancer and lymphoma and benefits of receiving this therapy. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Veliparib is not yet approved for use in the United States, and is considered experimental. Veliparib inhibits (blocks) the activity of the enzyme PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Nivolumab increases T cells in your immune system, which allows your immune system to attack the cancer. We think the combination of these drugs will be more effective against your cancer.
Primary Outcome
The MTD will be defined as the highest dose that causes dose-limiting toxicities (DLTs) in \<2 of 6 patients. Toxicity will be assessed using CTCAEv4.03. A DLT is defined as an Adverse Event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days (1 cycle) following the first dose of veliparib and nivolumab and meets any of the following criteria: Grade ≥ 3 non-hematologic toxicities that represent at least a 2-grade increase from baseli
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- OTHER Pharmacological Study
- DRUG Veliparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-05-23 |
| Est. Completion | 2020-08-04 |
| Phase | Phase 1 |
What the finished NCT03061188 record still lists
NCT03061188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03061188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03061188 about?
NCT03061188 is a clinical study titled "Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma". The purpose of this research study is to determine the highest and safest dose of the experimental drug veliparib when combined with nivolumab. We will also study how safely this combination of medication can be given in advanced cancer and lymphoma and benefits of receiving this therapy. Nivolumab ...
What is the current status of trial NCT03061188?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-05-23. Estimated completion is 2020-08-04.
What interventions are being tested in trial NCT03061188?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Pharmacological Study (OTHER), Veliparib (DRUG).
Who is sponsoring clinical trial NCT03061188?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061188's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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