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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 is a Phase 1 study that has completed, run by Richard Zellars. The registered enrollment target is 19 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01618357
The ClinicalTrials.gov registry entry for NCT01618357 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Richard Zellars, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Radiation is the first listed.
NCT01618357 reports 0 study locations.
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.
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