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NCT01732640 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC.
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01732640 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 9 participants.
The verdict
NCT01732640, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Trial Objectives: The objective is to investigate the efficacy and safety of afatinib with induction chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III or IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx. Primary Objective Phase I The primary objective of the phase I portion of the trial is to determine the maximum tolerated dose (MTD) or the recommended phase II dose of daily oral afatinib that is safe in combination with carboplatin AUC 6 and paclitaxel 175mg/m2 q 21 days as an induction regimen. Primary Objective Phase 2 The primary objective of the phase 2 portion of the trial is to estimate the objective tumor response rate and toxicity with induction therapy in patients treated on the afatinib dose determined in Phase I. Secondary Objectives The secondary objective of phase II is to estimate: 1) the overall response to entire treatment after completion of CRT, 2) progression-free survival (PFS) rate at 2 years, and 3) overall survival (OS) at 2 years.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Paclitaxel
- DRUG Afatinib
- RADIATION Intensity Modulated Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01732640
The ClinicalTrials.gov registry entry for NCT01732640 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01732640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01732640 about?
NCT01732640 is a clinical study titled "A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC.". Trial Objectives: The objective is to investigate the efficacy and safety of afatinib with induction chemotherapy in primary unresected patients with locally advanced, HPV-negative, stage III or IVa/b HNSCC including oral cavity, oropharynx, hypopharynx, or larynx. Primary Objective Phase I The pr...
What is the current status of trial NCT01732640?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-12. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01732640?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Paclitaxel (DRUG), Afatinib (DRUG), Intensity Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01732640?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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