A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
NCT01858389
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- Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
- Evidence of T790M mutation to enroll in Cohort A.
- Evidence of measurable disease by radiographic technique.
- Adequate organ function.
- Patients with T790M mutation who stopped any prior EGFR-directed therapy without
evidence of disease progression.
- Symptomatic brain metastases.
- Uncontrolled or significant cardiovascular disease.
- Pregnant or breastfeeding.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer | |||
Official Title ICMJE | Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc | |||
Brief Summary | This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Non-small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 41 | |||
Original Estimated Enrollment ICMJE | 35 | |||
Actual Study Completion Date ICMJE | September 2015 | |||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01858389 | |||
Other Study ID Numbers ICMJE | A7471047 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |