A clinical trial to study the pharmacokinetic comparision of two formulations of Docetaxel injections in Advanced Solid Tumor Patients
- Conditions
- Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
- Registration Number
- CTRI/2009/091/000316
- Lead Sponsor
- Intas Pharmaceuticals Limited India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1.The patient must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures.
2. Male and Female ≥18 years and < 65 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2.
3. Must have histopathologically /cytologically confirmed following primary tumors:
Breast cancer, Head and neck, Lung, Melanoma, or Prostate for which docetaxel is a viable treatment option.
4.Able to comply with study requirement in opinion of Principal Investigator.
1.Patient having hypersensitivity to Docetaxel injection
2. Intolerance to any antineoplastic agents belonging to the taxoid family.
3. Prior anticancer therapy within 21 days prior to the first day of study treatment.
4. Participation in another experimental drug study within 30 days prior to the first day of study treatment.
5.If bilirubin > ULN, or if SGOT and/or SGPT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN.
6. If neutrophil counts are < 1500 cells/mm3
7.Any other condition that, in the investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method