Phase 2
N=32
Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
Lung Neoplasms · Carcinoma, Non-small Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00094094 ↗Enrolled (actual)
32
Serious AEs
50.0%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Participants With Objective Response (OR) — 9.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- axitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
9.4 | — |
| SECONDARY Progression-Free Survival (PFS) |
148 | — |
| SECONDARY Duration of Response (DR) |
252 | — |
| SECONDARY Overall Survival (OS) |
450 | — |
Summary
This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage
Eligibility Criteria
Inclusion Criteria
- Histologically documented non-small cell lung cancer with metastases (Stage IV or recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.
- At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for localized disease does not count as a prior therapy for metastatic disease).
Exclusion Criteria
- Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
- Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients with a history of Grade 1 hemoptysis within 30 days of entry are not eligible
Data sourced from ClinicalTrials.gov (NCT00094094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.