NCT00313248 is a Phase 2 clinical trial of Sagopilone (ZK 219477) in Breast Neoplasm, sponsored by Bayer.

Who is sponsoring NCT00313248?

NCT00313248 is sponsored by Bayer.

What drugs are being tested in NCT00313248?

Interventions in NCT00313248: Sagopilone (ZK 219477), Sagopilone (ZK 219477).

What condition does NCT00313248 study?

NCT00313248 studies Breast Neoplasm.

Is NCT00313248 still recruiting?

NCT00313248 is currently completed. Last updated 11 November 2015.

Last reviewed 2015-11-11 · How we verify

NCT00313248

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

Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer

Completed Phase 2 Last updated 11 November 2015

What this trial tests

Phase 2 trial testing Sagopilone (ZK 219477) in Breast Neoplasm in 65 participants. Completed in 1 November 2008.

Timeline

1 April 2006

Primary endpoint
1 October 2008

1 November 2008

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	1 April 2006
Primary completion	1 October 2008
Estimated completion	1 November 2008
Sites	25 locations across United States, Canada

Drugs / interventions tested

Sagopilone (ZK 219477) — full drug profile →
Sagopilone (ZK 219477) — full drug profile →

Conditions studied

Breast Neoplasm — all drugs for Breast Neoplasm →

Sponsor

Bayer — full company profile →

Who can join

18 and older, female only, with Breast Neoplasm. 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.

Response to treatment with ZK-Epo after 6 cycles
Time frame: complete or partial response after 2 to 6 courses of therapy.

Sponsor's own description

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Breast Neoplasm

Currently open trials in the same condition.

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NCT06622967 — KNUCH CadAI-B-1(KCB-1) · NA · active not recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
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 NCT00313248 (US National Library of Medicine, public domain)
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: 11 November 2015

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/NCT00313248.

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