CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
axitinibdrug
Likely dose
Axitinib 5 mg orally twice daily in 4-week cyclesAI-extracted
Key inclusion· 2
  • Histologically documented NSCLC with metastases (Stage IV or recurrent) or locally advanced Stage IIIB with malignant pleural effusion
  • At least 1 prior systemic therapy for metastatic disease required (prior adjuvant therapy for localized disease does not count)
Key exclusion· 3
  • Central lung lesions involving major blood vessels (arteries or veins)
  • History of Grade 2 or worse hemoptysis
  • Grade 1 hemoptysis within 30 days of entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00094094
NCT00094094Phase 2Completed

Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer

Pfizer·interventional·Posted Oct 14, 2004·Updated Jun 26, 2012

In Brief

A Phase 2 clinical trial evaluating axitinib for Lung Neoplasms and Carcinoma, Non-small Cell Lung. Completed, enrolled 32 participants across 11 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 14, 2004
Enrollment StartFeb 1, 2005
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 21.7 years ago

Interventions

axitinibdrug

Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.