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NCT02277184 · ClinicalTrials.gov registry record · Phase 1
Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by Julie E. Bauman, MD, MPH.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02277184 is a Phase 1 study that was terminated before completion, run by Julie E. Bauman, MD, MPH. The registered enrollment target is 1 participants.
The verdict
NCT02277184, a Phase 1 study, was terminated before completion, sponsored by Julie E. Bauman, MD, MPH.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Head and neck squamous cell carcinoma (HNSCC) is the most common cancer arising in the upper aerodigestive tract, and is the sixth leading incident cancer worldwide. Despite advances in multimodality therapy, 5-year overall survival (OS) is 40-60%, and has increased only incrementally in the past two decades. The current standard of care for primary nonsurgical management of locally advanced HNSCC is concurrent cisplatin-radiotheray, which significantly improved OS, progression-free survival, and locoregional control compared with radiotherapy alone in the landmark Intergroup trial 0126. The MET proto-oncogene encodes c-Met, a heterodimeric growth factor receptor bound exclusively by its ligand, hepatocyte growth factor (HGF). In the laboratory, activation of the HGF/c-Met pathway is associated with resistance to cisplatin and radiotherapy in HNSCC. We hypothesize that the addition of an HGF/c-Met pathway inhibitor to cisplatin-radiotherapy may improve outcomes in HNSCC. Ficlatuzumab (AV-299) is a humanized HGF-inhibitory IgG1 monoclonal antibody. The primary objective of this study is to establish the recommended phase II dose (RP2D) of the combination of ficlatuzumab, cisplatin and intensity-modulated radiotherapy (IMRT), in patients with locally advanced HNSCC. The dose-finding study design will follow a Narayana k-in-a-row design with k set to 3 to target a 33% DLT rate. In the dose-finding phase, a total of either 10 or 14 patients will be treated. If no DLTs are observed among 10 patients, the highest dose tier will be declared the RP2D. Otherwise the RP2D will be estimated from DLTs across all dose levels by isotonic regression. The secondary objective is to estimate biomarker association with preliminary clinical response. We will evaluate biomarkers of HGF/cMet pathway activation in tumor tissue, plasma, and immune cells.
Interventions
- DRUG Cisplatin
- RADIATION Intensity Modulated Radiotherapy (IMRT)
- DRUG Ficlatuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02277184
The ClinicalTrials.gov registry entry for NCT02277184 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Julie E. Bauman, MD, MPH, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT02277184 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02277184 about?
NCT02277184 is a clinical study titled "Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma". Head and neck squamous cell carcinoma (HNSCC) is the most common cancer arising in the upper aerodigestive tract, and is the sixth leading incident cancer worldwide. Despite advances in multimodality therapy, 5-year overall survival (OS) is 40-60%, and has increased only incrementally in the past tw...
What is the current status of trial NCT02277184?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02277184?
The interventions under investigation include: Cisplatin (DRUG), Intensity Modulated Radiotherapy (IMRT) (RADIATION), Ficlatuzumab (DRUG).
Who is sponsoring clinical trial NCT02277184?
This trial is sponsored by Julie E. Bauman, MD, MPH, which has 4 total clinical trials registered on ClinicalTrials.gov.
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