NCT00432302 is a Phase 1 clinical trial of Sagopilone (BAY 86-5302, ZK 219477) in Neoplasms, sponsored by Bayer.

Who is sponsoring NCT00432302?

NCT00432302 is sponsored by Bayer.

What drugs are being tested in NCT00432302?

Interventions in NCT00432302: Sagopilone (BAY 86-5302, ZK 219477).

Is NCT00432302 still recruiting?

NCT00432302 is currently completed. Last updated 10 December 2015.

Last reviewed 2015-12-10 · How we verify

NCT00432302

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

Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design

Completed Phase 1 Last updated 10 December 2015

What this trial tests

Phase 1 trial testing Sagopilone (BAY 86-5302, ZK 219477) in Neoplasms in 7 participants. Completed in 1 November 2007.

Timeline

1 January 2007

Primary endpoint
1 November 2007

1 November 2007

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	1 January 2007
Primary completion	1 November 2007
Estimated completion	1 November 2007
Sites	1 location across Belgium

Drugs / interventions tested

Sagopilone (BAY 86-5302, ZK 219477) — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Neoplasms. 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.

Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
Time frame: 14 days
Cmax
Time frame: 14 days
Maximum plasma concentration for \[14C\]-ZK 219477, ZK 219477
tmax
Time frame: 14 days
Time to Cmax for \[14C\]-ZK 219477, ZK 219477
AUC
Time frame: 14 days
Area under the concentration time curve for \[14C\]-ZK 219477, ZK 219477
AUC(0-tlast)
Time frame: 14 days
AUC from administration until the last time point with measurable concentration for \[14C\]-ZK 219477, ZK 219477
AUC(0-24)
Time frame: 14 days
AUC from time zero to 24 hours for \[14C\]-ZK 219477, ZK 219477

Sponsor's own description

The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take

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 Neoplasms

Currently open trials in the same condition.

NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio · Phase 1 · recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms · Phase 1 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07257640 — IL-5 CAR-T Cell Therapy for Refractory/Relapsed Eosinophilic Leukemia · Phase 1 · recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer · Phase 1, PHASE2 · 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 NCT00432302 (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: 10 December 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/NCT00432302.

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