Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

NCT00862355 | Completed Phase 1

• 1 other identifier: DOX_2I_1476_09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence study of SPARC147609

Conditions

Ovarian Carcinoma

Keywords

Carcinoma; Ovary; Carcinoma Ovary

Outcome Measures

Primary Outcomes (1)

• 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product

  2 cycles

Secondary Outcomes (1)

• Treatment emergent adverse events

  2 cycles

Study Arms (2)

1

EXPERIMENTAL

SPARC147609

Drug: SPARC147609

2

ACTIVE COMPARATOR

Reference147609

Drug: Reference147609

Interventions

SPARC147609 DRUG

IV infusion

1

Reference147609 DRUG

IV infusion

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (1)

SPARC Site 1

Hyderabaad, Andhra Pradesh, India

Location

Related Publications (1)

• 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.

  PMID: 29995186 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 16, 2009
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

IN (1)