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
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ClinicalTrials.gov Identifier: NCT01647711 |
Recruitment Status :
Completed
First Posted : July 23, 2012
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Non-Small-Cell Lung |
Intervention |
Drug: Dose escalation followed by treatment with MTD |
Enrollment | 35 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Afatinib was administered until disease progression, however patients experiencing clinical benefit were allowed to continue treatment for as long as judged beneficial by the investigator. |
Arm/Group Title | Afatinib 90mg | Afatinib 120mg | Afatinib 150mg | Afatinib 160mg | Afatinib 200mg |
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Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. |
Period Title: Overall Study | |||||
Started | 6 | 3 | 9 | 11 | 6 |
Completed | 0 | 0 | 0 | 0 | 0 |
Not Completed | 6 | 3 | 9 | 11 | 6 |
Reason Not Completed | |||||
Progressive disease | 6 | 2 | 6 | 8 | 2 |
Other adverse event | 0 | 0 | 2 | 0 | 2 |
Protocol Violation | 0 | 0 | 0 | 0 | 1 |
Refused to continue taking medication | 0 | 0 | 0 | 2 | 1 |
Other reason not defined | 0 | 1 | 1 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Afatinib 90mg | Afatinib 120mg | Afatinib 150mg | Afatinib 160mg | Afatinib 200mg | Total | |
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Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle. | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 3 | 9 | 11 | 6 | 35 | |
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Treated set which included all patients who took at least one dose of afatinib.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 6 participants | 3 participants | 9 participants | 11 participants | 6 participants | 35 participants | |
65.0
(64 to 80)
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58.0
(50 to 77)
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65.0
(54 to 77)
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61.0
(45 to 70)
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62.5
(54 to 75)
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64.0
(45 to 80)
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Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 3 participants | 9 participants | 11 participants | 6 participants | 35 participants | |
Female |
2 33.3%
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1 33.3%
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6 66.7%
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10 90.9%
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5 83.3%
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24 68.6%
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Male |
4 66.7%
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2 66.7%
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3 33.3%
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1 9.1%
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1 16.7%
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11 31.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
One patient was screened in part B of the study, the patient did not meet eligibility requirements and was not treated. The trial completed enrollment in Part A before any additional patients were screened for Part B.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title: | Boehringer Ingelheim Call Center |
Organization: | Boehringer Ingelheim |
Phone: | 1-800-243-0127 |
EMail: | clintriage.rdg@boehringer-ingelheim.com |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01647711 |
Other Study ID Numbers: |
1200.121 |
First Submitted: | July 16, 2012 |
First Posted: | July 23, 2012 |
Results First Submitted: | September 22, 2016 |
Results First Posted: | January 31, 2017 |
Last Update Posted: | January 31, 2017 |