NCT05567601 is a Phase 1 clinical trial of DOXIL/CAELYX in Ovarian Cancer, sponsored by Baxter Healthcare Corporation.

Who is sponsoring NCT05567601?

NCT05567601 is sponsored by Baxter Healthcare Corporation.

What drugs are being tested in NCT05567601?

Interventions in NCT05567601: DOXIL/CAELYX.

What condition does NCT05567601 study?

NCT05567601 studies Ovarian Cancer, AIDS-related Kaposi Sarcoma, Multiple Myeloma, Metastatic Breast Cancer.

Is NCT05567601 still recruiting?

NCT05567601 is currently completed. Last updated 5 June 2025.

Last reviewed 2025-06-05 · How we verify

NCT05567601

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

Doxil/Caelyx BE Study

Completed Phase 1 Last updated 5 June 2025

What this trial tests

Phase 1 trial testing DOXIL/CAELYX in Ovarian Cancer in 36 participants. Completed in 21 June 2024.

Timeline

16 December 2023

Primary endpoint
21 June 2024

21 June 2024

Quick facts

Lead sponsor	Baxter Healthcare Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	16 December 2023
Primary completion	21 June 2024
Estimated completion	21 June 2024
Sites	14 locations across India

Drugs / interventions tested

DOXIL/CAELYX — full drug profile →

Conditions studied

Ovarian Cancer — all drugs for Ovarian Cancer →
AIDS-related Kaposi Sarcoma — all drugs for AIDS-related Kaposi Sarcoma →
Multiple Myeloma — all drugs for Multiple Myeloma →
Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Baxter Healthcare Corporation — full company profile →

Who can join

Adults 18 to 75, any sex, with Ovarian Cancer or AIDS-related Kaposi Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.

Publications & conference data

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

Nanomedicine strategies for cuproptosis: Metabolic reprogramming and tumor immunotherapy.
Zhang R, Li Y, Fu H, Zhao C, et al · · 2025 · cited 8× · PMID 41049741 · DOI 10.1016/j.apsb.2025.07.007

Verify or expand the search:

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Baxter Healthcare Corporation trials

Trials by the same sponsor.

NCT07256951 — Gen 2 Battrode Wear Study · NA · recruiting
NCT07158333 — Mobile Cardiac Telemetry (MCT) Study · completed
NCT06842121 — A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Ph · Phase 1 · completed
NCT06842134 — A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E · Phase 1 · completed
NCT05996809 — PMCF Study for COSEAL® in Gynecologic Surgery · completed

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 NCT05567601 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Baxter Healthcare Corporation
Last refreshed: 5 June 2025

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/NCT05567601.

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