Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
1 other identifier
interventional
29
0 countries
N/A
Brief Summary
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2009
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedJuly 23, 2021
July 1, 2021
1.2 years
February 7, 2017
July 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum measured plasma concentration
336 hours
Secondary Outcomes (1)
The area under the plasma concentration versus time curve from time 0 to infinity
336 hours
Study Arms (2)
SPARC-08-038
EXPERIMENTAL2 mg/ml
Ref-08-038
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
- Subjects who had no evidence of underlying disease
- Subjects who had signed written consent form
You may not qualify if:
- Females who were pregnant, breastfeeding, or are likely to become pregnant
- Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
- Subjects deemed uncooperative or noncompliant
- Smoking or consumption of any nicotine products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29995186DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 16, 2017
Study Start
September 3, 2008
Primary Completion
November 28, 2009
Study Completion
November 28, 2009
Last Updated
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share