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

• Status: Completed
• Trial end date: 2009-11-28
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

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