A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Nanosomal Docetaxel Lipid Suspension for Injection in Locally Advanced or Metastatic Breast Cancer Patients.

Not Applicable

Completed

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2014/11/005204
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

An Open Label,parallel, randomized Study to Evaluate the Pharmacokinetics, Safety andEfficacy at three doses of Nanosomal Docetaxel Lipid Suspension for Injectionin Locally Advanced or Metastatic Breast Cancer Patients after failure of priorchemotherapy.

Drug will beadministered by IV infusion over 1 hour at a dose of 60, 75 and 100 mg/m2.Patients will be treated every 21 days (a treatment cycle) in the absence ofdisease progression or unacceptable toxicity. Disease status and tumor responsewill be assessed after every 3 cycles of treatment using Response EvaluationCriteria in Solid Tumors (RECIST version 1.1) guidelines through cycle 6(including confirmation of response if required); subsequent cycles will followinstitutional standards for tumor/disease assessment.

The proposed study willevaluate the safety, efficacy and exposure response relationship at three doselevel for Nanosomal Docetaxel Lipid Suspension (NDLS) in breast cancerPatients. Based on the goals of therapy and the individual characteristics ofthe patient, each of the doses being studied in this trial may be appropriate,with lower doses having potential utility in patients who are frail or havespecific tolerability concerns.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-24
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 1.The patient willing to give written signed and dated informed consent to participate in the study.
• 2.Female ≥18 years and ≤65 years of age.
• 3.Patient must have histopathologically /cytologically confirmed breast cancer.
• 4.Patient must have locally advanced or metastatic breast cancer after failure of chemotherapy.
• Prior chemotherapy should have included an anthracycline unless clinically contraindicated 5.Have at least one measurable lesion as per the RECIST criteria (version 1.1).
• 6.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 7.Left Ventricular Ejection fraction (LVEF) ≥ 50% as per Echocardiography (ECHO).
• 8.Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.
• 9.Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IMP administration.
• 10.Patients with life expectancy of at least 6 months.
• 11.Serum pregnancy test at screening and urine pregnancy test on Day 1(before randomization) must be negative.
• 12.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug.
• Cessation of birth control after this point should be discussed with a responsible physician.
• (It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document.
• The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol).
• 13.Patient with adequate bone marrow, renal and hepatic function.

Exclusion Criteria

• 1.Patient who has a history of hypersensitivity reactions to docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.
• 2.Patients with HER2+ status 3.Patient who is already exposed to docetaxel injection.
• 4.Any of the following cardiac conditions: a.Unstable angina b.Myocardial infarction within the past 6 months c.Severe uncontrolled ventricular arrhythmias d.Clinically significant pericardial disease e.Electrocardiographic evidence of acute ischemia f.Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months g.History of cardiac disease that met the NYHA Classification class 2 or greater.
• 5.Uncontrolled diabetes or infection.
• 6.Known history of drug addiction within last 1 year.
• 7.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
• 8.The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study.
• 9.Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 as defined by NCI CTCAE 4.03 criteria.
• 10.Known case of HIV infection.
• 11.Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
• 12.Patients who are unwilling or unable to follow protocol requirements.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• To compare safety, pharmacokinetics (PK) of NDLS at three dose levels in locally advanced or metastatic breast cancer patients.	6 cycles

Secondary Outcome Measures

Name	Time	Method
• To compare the BOR (CR or PR) to evaluate the efficacy of NDLS	6 cycles
• To evaluate the exploratory exposure-response relationship for NDLS in patients for efficacy and toxicity in locally advanced or metastatic breast cancer	6 cycles

Trial Locations

Locations (16)

Acharya Tulsi Regional Cancer Treatment & Research Institute; 🇮🇳 Bikaner, RAJASTHAN, India

Apple Hospital; 🇮🇳 Surat, GUJARAT, India

BIBI General Hospital & Cancer Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Cancer Clinic & Nursing Home; 🇮🇳 Nagpur, MAHARASHTRA, India

City Cancer Centre; 🇮🇳 Krishna, ANDHRA PRADESH, India

Curie Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Erode Cancer centre; 🇮🇳 Erode, TAMIL NADU, India

Government Medical College and hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

King Geroges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Meenakshi Mission Hospital and Research Centre; 🇮🇳 Madurai, TAMIL NADU, India

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Acharya Tulsi Regional Cancer Treatment & Research Institute

🇮🇳Bikaner, RAJASTHAN, India

Dr Neeti Sharma

Principal investigator

9461159531

drneetisharma@rediffmail.com