Clinical trial NCT00862355: Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Carcinoma
Keywords: Carcinoma
Ovary
Carcinoma Ovary
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Bioequivalence study of SPARC147609


Eligibility criteria: Inclusion Criteria:

* Subjects meeting all of the following criteria will be considered for enrollment in the study:

  * Availability of subject for the entire study period and willingness to adhere to protocol requirements.
  * Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
  * Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
  * Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
  * Informed consent form given in written form.

Exclusion Criteria:

* History or presence of significant:

  * Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
  * Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
  * Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
  * Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg.
  * Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
* Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
* Participation in another clinical trial within the preceding 90 days of study start
* Subjects who have:

  * Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
  * Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
  * Pulse rate below 60/min. or above 100/min

Primary outcomes:
measure: 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product
timeFrame: 2 cycles
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: 2 cycles
Other outcomes:
Locations:
city: Hyderabaad
country: India
facility: SPARC Site 1
state: Andhra Pradesh
Study officials:
References:
citation: 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.