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NCT01647711 · ClinicalTrials.gov registry record · Phase 1
A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT01647711: Completed Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Boehringer Ingelheim.
NCT01647711 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that has completed, run by Boehringer Ingelheim. The registered enrollment target is 35 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647711, a Phase 1 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M mutations to a dose of intermittent afatinib established in Part A. The secondary objective is to explore tumor response and tumor-derived biological markers of response to afatinib, as well as pharmacokinetic parameters of afatinib.
Primary Outcome
Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.
Conditions Studied
Interventions
- DRUG Dose escalation followed by treatment with MTD
Study Locations (2)
Colorado
- Boehringer Ingelheim Investigational Site - Aurora
Massachusetts
- Boehringer Ingelheim Investigational Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT01647711 record still lists
NCT01647711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 1 intervention - of which Dose escalation followed by treatment with MTD is the first listed.
NCT01647711 reports a single indexed study location in Colorado, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01647711 about?
NCT01647711 is a clinical study titled "A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations". This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M mutations to a dose ...
What is the current status of trial NCT01647711?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2012-07. Estimated completion is 2015-09.
What conditions does trial NCT01647711 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT01647711?
The interventions under investigation include: Dose escalation followed by treatment with MTD (DRUG).
Who is sponsoring clinical trial NCT01647711?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01647711 being conducted?
This trial has 2 study locations across Colorado, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01647711's enrollment target sits among peer trials
35 104th of 130 higher than 24 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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.
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