Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer and Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ref-08-038 | Drug | — | UNRESOLVED |
| SPARC-08-038 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPARC-08-038
- description
- 2 mg/ml
- interventionNames
- Drug: SPARC-08-038
- Drug: Ref-08-038
- type
- ACTIVE_COMPARATOR
- label
- Ref-08-038
- interventionNames
- Drug: SPARC-08-038
- Drug: Ref-08-038
Primary outcomes (1)
- measure
- Maximum measured plasma concentration
- timeFrame
- 336 hours
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 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: 1. Females who were pregnant, breastfeeding, or are likely to become pregnant 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
References
Publications (1)
- DERIVEDBhowmik 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 29995186