A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804
NCT00971191
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- Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
- Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.
- Prior or concurrent systemic anticancer therapy for cancer (immunotherapy,
hormonotherapy, biological therapy, or chemotherapy) less than one year from time of
consent.
- Prior or concurrent radiation therapy to tumor at site of planned resection.
- Congestive heart failure (LVEF < 50%), uncontrolled hypertension, significant
ventricular arrythmia.
- Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to
have a risk of causing Torsades de Pointes.
- Prior or concurrent radiation therapy to tumor at site of planned resection.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804 | |||
| Official Title ICMJE | A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804 | |||
| Brief Summary | This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug. | |||
| Detailed Description | The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in February 2010. Based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. The discontinuation of the study is not due to any safety issue. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Non-Small Cell Lung Cancer (NSCLC) | |||
| Intervention ICMJE | Drug: PF-00299804
Brief exposure (5- 11 days) to study drug prior to surgical resection | |||
| Study Arms ICMJE | Experimental: treatment
Patients treated with brief exposure to PF-00299804 prior to surgical resection Intervention: Drug: PF-00299804 | |||
| Publications * | Not Provided | |||
* 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 | Terminated | |||
| Actual Enrollment ICMJE | 22 | |||
| Original Estimated Enrollment ICMJE | 75 | |||
| Actual Study Completion Date ICMJE | May 2012 | |||
| Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00971191 | |||
| Other Study ID Numbers ICMJE | A7471031 | |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||