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

Sun Pharma Advanced Research Company Limited29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Breast Cancer and Ovarian Cancer

Interventions

SPARC-08-038DRUG

2 mg/ml intravenous infusion

Ref-08-038DRUG

2 mg/ml intravenous infusion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years. 3. Subjects who had no evidence of underlying disease 4. Subjects who had signed written consent form Exclusion Criteria: 1. Females who were pregnant, breastfeeding, or are likely to become pregnant 2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results 3. Subjects deemed uncooperative or noncompliant 4. Smoking or consumption of any nicotine products

Outcomes

Primary Outcomes

Maximum measured plasma concentration

Time frame: 336 hours

Secondary Outcomes

The area under the plasma concentration versus time curve from time 0 to infinity

Time frame: 336 hours

Data from ClinicalTrials.gov

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