Safety, efficacy and pharmacokinetic study of paclitaxel injection concentrate for nano-dispersion in subjects with metastatic breast cancer.

Phase 1

Completed

• Conditions: Health Condition 1: null- Female subjects 18 to 75-years of age with confirmed diagnosis of breast cancer and the performance status â?¤ 2 on the ECOG performance scale (life expectancy of at least 12-weeks)Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2009/091/000262
• Lead Sponsor: Sun Pharma Advanced Research Company Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-09-29
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of breast cancer after failure of combination chemotherapy for metastatic disease.

•Female subjects with age 18 to 75-years inclusive;

•Performance status <= 2 on the ECOG performance scale

•Must have estimated life expectancy of at least 12-weeks;

•Measurable or evaluable disease as per RECIST criteria;

•Must have adequate organ and immune system function as indicated by the following laboratory values, obtained <= 2 weeks prior to enrollment:

ANC >= 1.5 Ã? 109 /L; Hb >= 9.0 g/dL; Platelets>= 100 Ã? 109 /L; Sr Creatinine: <= 2.0 mg/dL; Total Bilirubin<= 1.5 mg/dL or <= 2 mg/dL (for liver mets); AST & ALT<= 2.5 Ã? ULN or <= 5 Ã? ULN (for liver mets) Alkaline phosphatase<= 5 Ã? ULN (unless bone mets are present in the absense of liver mets); Serum Calcium WNL

•Any chemotherapy (except taxanes), major surgery, or irradiation must have been completed at least 4-weeks before enrollment in this study (6-weeks for Mitomycin C or nitrosurea); subjects must have recovered from all toxicities incurred as a result of previous therapy;

•Prior chemotherapy containing taxanes must have been completed at least 48-weeks before enrollment in this study;

•If subject has received taxanes as adjuvant therapy, she must not have relapsed with breast cancer within 48-weeks of completing adjuvant taxane therapy;

•Prior hormonal therapy for breast cancer must have been completed at least 2-weeks before enrollment in this study;

•Female subjects with childbearing potential must have negative serum pregnancy test within last 7-days of study enrollment. Women of reproductive potential must use an effective contraceptive method while enrolled in the study;

•Willing to participate and give written informed consent.

Exclusion Criteria

•Uncontrolled angina, subjects with a history of myocardial infarction within 2-months of enrollment, or subjects with cardiac functional capacity Class III or IV as defined by NYHA classification;

•Known hypersensitivity to study drugs or its excipients or analogs;

•Treatment with any investigational agents within 30-days of study entry;

•Active and uncontrolled infection;

•Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow-up;

•Presence of clinically apparent CNS metastases or carcinomatous meningitis;

•Subjects with diabetes mellitus;

•Pre-existing peripheral neuropathy (grade 1 or higher â?? as per CTCAE);

•Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;

•HIV positive or who have an AIDS-related illness;

•Prior radiation therapy to >=25% of the bone marrow (e.g. whole pelvic radiation is allowed). Subjects must have recovered from the acute side effects of radiotherapy;

•Prior bone marrow/stem cell transplantation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified