NCT00359359 is a Phase 1/Phase 2 clinical trial of Sagopilone (BAY86-5302, ZK 219477) in Carcinoma, Small Cell, sponsored by Bayer.

Who is sponsoring NCT00359359?

NCT00359359 is sponsored by Bayer.

What drugs are being tested in NCT00359359?

Interventions in NCT00359359: Sagopilone (BAY86-5302, ZK 219477), Cisplatin.

What condition does NCT00359359 study?

NCT00359359 studies Carcinoma, Small Cell.

Is NCT00359359 still recruiting?

NCT00359359 is currently completed. Last updated 3 November 2014.

Last reviewed 2014-11-03 · How we verify

NCT00359359

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)

Completed Phase 1/Phase 2 Last updated 3 November 2014

What this trial tests

Phase 1/Phase 2 trial testing Sagopilone (BAY86-5302, ZK 219477) in Carcinoma, Small Cell in 26 participants. Completed in 1 August 2009.

Timeline

1 July 2006

Primary endpoint
1 March 2009

1 August 2009

Quick facts

Lead sponsor	Bayer
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 July 2006
Primary completion	1 March 2009
Estimated completion	1 August 2009
Sites	10 locations across Germany

Drugs / interventions tested

Sagopilone (BAY86-5302, ZK 219477) — full drug profile →
Cisplatin (cisplatin) — full drug profile →

Conditions studied

Carcinoma, Small Cell — all drugs for Carcinoma, Small Cell →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Small Cell. 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.

Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
Time frame: Phase 1: Baseline up to 3 month of treatment
Phase 2: Efficacy measure
Time frame: Phase 2: every 6 weeks after start of treatment

Sponsor's own description

The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A novel mutation panel for predicting etoposide resistance in small-cell lung cancer.
Qiu Z, Lin A, Li K, Lin W, et al · · 2019 · cited 45× · PMID 31417239 · DOI 10.2147/dddt.s205633

Verify or expand the search:

Other recruiting trials for Carcinoma, Small Cell

Currently open trials in the same condition.

NCT04660929 — CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors · Phase 1 · active not recruiting

Other Bayer trials

Trials by the same sponsor.

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NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00359359 (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: 3 November 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/NCT00359359.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing