Last reviewed · How we verify
NCT00160069
Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)
Phase 2 trial testing Sagopilone (BAY86-5302, ZK 219477) in Carcinoma, Non Small Cell Lung in 128 participants. Completed in 1 April 2009.
1 April 2008
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 1 August 2005 |
| Primary completion | 1 April 2008 |
| Estimated completion | 1 April 2009 |
| Sites | 17 locations across Germany |
Drugs / interventions tested
- Sagopilone (BAY86-5302, ZK 219477) — full drug profile →
- Sagopilone (BAY86-5302, ZK 219477) — full drug profile →
- Sagopilone (BAY86-5302, ZK 219477) — full drug profile →
Conditions studied
- Carcinoma, Non Small Cell Lung — all drugs for Carcinoma, Non Small Cell Lung →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Carcinoma, Non Small Cell Lung. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
Time frame: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
Sponsor's own description
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review.
Chan SHY, Khatib Y, Webley S, Layton D, et al · · 2023 · cited 10× · PMID 37383708 · DOI 10.3389/fphar.2023.1137983
Verify or expand the search:
- PubMed search for NCT00160069
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Bayer trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00160069 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 2 December 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00160069.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing