Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer

Phase 1 Completed 29 enrolled Sun Pharma Advanced Research Company Limited

RandomizedCrossoverTreatment

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.

Timeline

Start: 2008-09-03
Primary completion: 2009-11-28
Completion: 2009-11-28

Outcome

Met primary endpoint

paper Bioequivalence between the test and the reference products was established for total and encapsulated DXR in both studies PMID 29995186 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ref-08-038	Unknown	50 mg/m2	Intravenous
Subject	SPARC-08-038	Unknown	50 mg/m2	Intravenous

Indications

No indication recorded.