Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Carcinoma, Non-Small Cell Lung

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

FieldValue
Enrollment Target 35 participants
Start Date 2012-07
Est. Completion 2015-09
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01647711

The ClinicalTrials.gov registry entry for NCT01647711 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (89% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Carcinoma, Non-Small Cell Lung

All registered trials for this condition

Colorado

All trials with a study site in Colorado

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.