Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00862355
• Date of registration: 13/03/2009
• Prospective Registration: Yes
• Primary sponsor: Sun Pharma Advanced Research Company Limited
• Public title: Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer
• Date of first enrolment: March 2010
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00862355
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

India

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Carcinoma

Intervention(s)

Drug: Reference147609

Drug: SPARC147609

Primary Outcome(s)

90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-8, of the test and reference product [Time Frame: 2 cycles]

Secondary Outcome(s)

Treatment emergent adverse events [Time Frame: 2 cycles]

Secondary ID(s)

DOX_2I_1476_09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors