A study to Assess the Safety and Efficacy of Docetaxel Lipid Suspension (DLS) for Injection of Intas Pharmaceuticals Limited, India in Lung Cancer patients.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2017/04/008305
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patient willing and able to give informed consent to participate in the study.
2. Male and Female patients >=18 years and <=65 years of age at screening.
3. Patient with histologically/cytologically confirmed locally advanced or metastatic NSCLC after platinum therapy failure.
4. Patient should have at least one measurable lesion as per RECIST 1.1.
5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function as
defined by the following parameters
-Bone marrow function-ANC greater than 1500/mm3, Platelet count greater than 100,000/mm3. Hemoglobin Greater than 9.0 g/dL.
-Renal function- Serum Creatinine < 1.5 times ULN.
-Hepatic function- Serum Bilirubin
-LVEF- > 50%.
6. Patient should be able to comply with study procedures in the opinion of the investigator.
7. Patient with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG)
8. Patient with Life expectancy more than six months
9. Serum pregnancy test at screening and urine pregnancy test on Day 1(before dosing) of each cycle must be negative.
10. Male or Female patients or their partner must agree to use effective measures of contraception during the study.
(It is investigatorâ??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.)
1. Patient with the history of hypersensitivity reactions to Taxanes or any other component of formulation.
2. Chronic treatment with systemic steroids or another immunosuppressive agent or patient with severely immunocompromised state.
3. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
4. Major surgery within 4 weeks prior to dosing or planned major surgery.
5. Patient treated with radiotherapy/and adjuvant chemotherapy within 30 days prior to screening
6. Patient with known CNS lesions (brain metastasis or carcinomatous meningitis).
7. Any history or presence of clinically significant cardiovascular, respiratory, hepatic,renal, hematologic, gastrointestinal, endocrine, immunologic,dermatologic,neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results.
8. Patients with hepatitis B or hepatitis C infection or known case of HIV infection.
9. Pregnant or breast-feeding patients.
10. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 as defined by NCI CTCAE 4.03 criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Docetaxel Lipid Suspension for Injection 20/80 mg/vial, Manufactured by Intas Pharmaceuticals Limited, India in the patients with <br/ ><br>Non-Small Cell Lung Cancer.Timepoint: 6 Cycles
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of Docetaxel Lipid Suspension for <br/ ><br>Injection 20/80 mg/vial, Manufactured by Intas Pharmaceuticals Limited, India in Non-Small <br/ ><br>Cell Lung Cancer patients.Timepoint: 6 Cycles