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NCT01618357 · ClinicalTrials.gov registry record · Phase 1
Pre-Operative Radiation and Veliparib for Breast Cancer
A Phase 1 study, sponsored by Richard Zellars.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01618357: Completed Phase 1 study, sponsored by Richard Zellars.
NCT01618357 is a Phase 1 study that has completed, run by Richard Zellars. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618357, a Phase 1 study, has completed, sponsored by Richard Zellars.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The investigators' primary aim is to determine the safety, tolerability and maximum tolerated dose (within 50 - 200mg/BID dose range) when combining veliparib and radiation. The investigators' exploratory aim is to serially assess apoptosis/proliferation biomarkers, and gene and protein expression profiles for correlation with tumor response to POPI. Study Plan: It will be a standard 3+3 dose finding trial in which the MTD will be defined as the dose below the level at which \>1 DLT is observed in 3-6 patients. Women with node positive disease prior to NAC and \>1.0 cm residual breast disease and/or clinically positive nodal disease after NAC will be offered participation in the research phase of this study. Women with residual disease \>1cm or +/-LN after NAC (Med Onc's choice) will be offered pre-operative Veliparib and concurrent whole breast and regional nodal irradiation. Four (4) dose levels of Veliparib will be evaluated with concurrent whole breast and regional nodal irradiation (WB/RNI). The starting dose of Veliparib will be 50 mg BID, will increase in 50 mg increments to a maximum of 200 mg BID and be delivered concurrently with 235 cGy QD x 16 to the breast and SCV/Axilla. Accrual: Up to 41 patients
Primary Outcome
To determine the safety, tolerability and maximum tolerated dose (within 50 - 200 mg/BID dose range) when combining Veliparib and radiation.
Interventions
- RADIATION Radiation
- DRUG Veliparib
- PROCEDURE Lumpectomy/Mastectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-07-22 |
| Est. Completion | 2023-10-17 |
| Phase | Phase 1 |
What the finished NCT01618357 record still lists
NCT01618357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Radiation is the first listed.
NCT01618357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01618357 about?
NCT01618357 is a clinical study titled "Pre-Operative Radiation and Veliparib for Breast Cancer". The investigators' primary aim is to determine the safety, tolerability and maximum tolerated dose (within 50 - 200mg/BID dose range) when combining veliparib and radiation. The investigators' exploratory aim is to serially assess apoptosis/proliferation biomarkers, and gene and protein expression ...
What is the current status of trial NCT01618357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2013-07-22. Estimated completion is 2023-10-17.
What interventions are being tested in trial NCT01618357?
The interventions under investigation include: Radiation (RADIATION), Veliparib (DRUG), Lumpectomy/Mastectomy (PROCEDURE).
Who is sponsoring clinical trial NCT01618357?
This trial is sponsored by Richard Zellars, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01618357's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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