Clinical trial · Interventional
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
A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
NCT00971191CI-TRIAL-00007238terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-00299804 | Drug | Dacomitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Patients treated with brief exposure to PF-00299804 prior to surgical resection
- interventionNames
- Drug: PF-00299804
Primary outcomes (1)
- measure
- To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose
- timeFrame
- 30 months
Secondary outcomes (4)
- measure
- To correlate molecular changes with specific gene and protein changes (eg, mutations, amplifications, over expression) in members of the EGFR and HER2 signal transduction pathways (eg, KRAS, EGFR, HER2)
- timeFrame
- 30 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.