A study to compare two forms/formulations of Paclitaxel Injectable Suspension in metastatic Breast cancer patients

Not Applicable

Completed

• Conditions: Health Condition 1: C50- Malignant neoplasm of breast

• Registration Number: CTRI/2020/09/028155
• Lead Sponsor: Mylan Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-30
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 111

Inclusion Criteria

1.Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6months of adjuvant chemotherapy (Prior therapy should have included anthracycline unless clinically contraindicated)

2.Male and/or non-pregnant, non-lactating females aged 18 years or older but less than 70 years (both inclusive)

3. ECOG performance status of less or equal 2

4.Adequate hemopoietic, renal and liver function.

5.Patients receiving stable concomitant medications are allowed to participate

6.Treated and stable brain metastases

Exclusion Criteria

1.Social Habits (for example) ingestion of alcoholic beverages, caffeine- or xanthine-containing food or beverage.

2.Use of any food (e.g. broccoli, Brussels sprouts, char-grilled meat, star fruit) known to induce or inhibit hepatic enzyme activity must be limited to no more than 2 standard servings.

3. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies except the disease/metastasis under study unless deemed not clinically significant by the Investigator

4.Patients who require a dose reduction to below 260 mg/m2.

5.Received chemotherapy and/ or radiotherapy within the past 30 days of first IMP

administration or has not recovered from the side effects of previous therapy or has less than 5 washout periods from previous therapy. The toxicities should not

be more than grade 1 at the time of dosing.

6.History of significant uncontrolled cardiac disease (i.e. unstable angina, recent

myocardial infarction within prior 6 months), patients classified as having a New

York Heart Association (NYHA) class III or IV congestive heart failure.

7.Known, existing uncontrolled coagulopathy.

8.Patients with another primary malignancy except if the other primary malignancy

is neither currently clinically significant or requiring active intervention.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified