NCT00288249 is a Phase 2 clinical trial of Sagopilone (BAY86-5302, ZK 219477) in Breast Neoplasms, sponsored by Bayer.

Who is sponsoring NCT00288249?

NCT00288249 is sponsored by Bayer.

What drugs are being tested in NCT00288249?

Interventions in NCT00288249: Sagopilone (BAY86-5302, ZK 219477), Sagopilone (BAY86-5302, ZK 219477), Sagopilone (BAY86-5302, ZK 219477), Sagopilone (BAY86-5302, ZK 219477).

What condition does NCT00288249 study?

NCT00288249 studies Breast Neoplasms, Breast Cancer, Metastatic.

Is NCT00288249 still recruiting?

NCT00288249 is currently completed. Last updated 27 November 2014.

Last reviewed 2014-11-27 · How we verify

NCT00288249

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

Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

Completed Phase 2 Last updated 27 November 2014

What this trial tests

Phase 2 trial testing Sagopilone (BAY86-5302, ZK 219477) in Breast Neoplasms in 82 participants. Completed in 1 January 2009.

Timeline

1 December 2005

Primary endpoint
1 March 2008

1 January 2009

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 December 2005
Primary completion	1 March 2008
Estimated completion	1 January 2009
Sites	21 locations across Austria, Belgium, Bulgaria, France, Germany, Italy, Poland, Slovenia

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

Conditions studied

Breast Neoplasms — all drugs for Breast Neoplasms →
Breast Cancer, Metastatic — all drugs for Breast Cancer, Metastatic →

Sponsor

Bayer — full company profile →

Who can join

18 and older, female only, with Breast Neoplasms or Breast Cancer, Metastatic. 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.

Tumor response rate (complete or partial response according to RECIST)
Time frame: Every 6 weeks
The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).

Sponsor's own description

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

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 Neoplasms

Currently open trials in the same condition.

NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · 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 NCT00288249 (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: 27 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/NCT00288249.

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