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

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer and Ovarian Cancer

Treatments: Drug: Ref-08-038; Drug: SPARC-08-038

Study type: Interventional

Funder types: Industry

Identifiers

NCT03055143

PKD/08/038

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 2 patient groups

SPARC-08-038

Experimental group

Description:

2 mg/ml

Treatment:

Drug: SPARC-08-038

Drug: Ref-08-038

Ref-08-038

Active Comparator group

Treatment:

Drug: SPARC-08-038

Drug: Ref-08-038