Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Ovarian Carcinoma

Treatments: Drug: SPARC147609; Drug: Reference147609

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862355

DOX_2I_1476_09

Details and patient eligibility

About

Bioequivalence study of SPARC147609

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

SPARC147609

Treatment:

Drug: SPARC147609

2

Active Comparator group

Description:

Reference147609

Treatment:

Drug: Reference147609