Clinical trial · Interventional
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
NCT00160043CI-TRIAL-00016348completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTK787/ ZK 222584 | Drug | Vatalanib | ALIAS |
| SH T00268C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: SH T00268C
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: PTK787/ ZK 222584
Primary outcomes (1)
- measure
- Tumor response rate (complete or partial response according to RECIST).
- timeFrame
- At baseline and every 8 weeks afterwards
Secondary outcomes (1)
- measure
- Time to disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non small cell lung cancer, Stage IIIB or Stage IV * One and only 1 prior platinum-based chemotherapy * No other uncontrolled concurrent illness * Use of highly effective birth control methods in males or females with reproductive potential Exclusion Criteria: * Previous participation in another trial within the last 4 weeks * Surgery within 10 days prior to the start of study treatment * Brain metastases * Confirmed diagnosis of infection with the human immunodeficiency virus (HIV) * Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication * Breast feeding
References
Publications (1)
- RESULTGauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26. PMID 21617019