Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
NCT ID: NCT03055143
Last Updated: 2021-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2008-09-03
2009-11-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (Lipodox®) in Chinese Patients
NCT05273944
Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years
NCT00563953
A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
NCT04460820
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
NCT06098599
A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer
NCT03017404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPARC-08-038
2 mg/ml
SPARC-08-038
2 mg/ml intravenous infusion
Ref-08-038
2 mg/ml intravenous infusion
Ref-08-038
SPARC-08-038
2 mg/ml intravenous infusion
Ref-08-038
2 mg/ml intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPARC-08-038
2 mg/ml intravenous infusion
Ref-08-038
2 mg/ml intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
3. Subjects who had no evidence of underlying disease
4. Subjects who had signed written consent form
Exclusion Criteria
2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
3. Subjects deemed uncooperative or noncompliant
4. Smoking or consumption of any nicotine products
18 Years
55 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
Bhowmik S, Bhowmick S, Maiti K, Chakra A, Shahi P, Jain D, Rajamannar T. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil(R) or Caelyx(R) in advanced ovarian cancer. Cancer Chemother Pharmacol. 2018 Sep;82(3):521-532. doi: 10.1007/s00280-018-3643-3. Epub 2018 Jul 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PKD/08/038
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.