Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified
Conditions
Interventions
Intervention1: Gemcitabine Injection Concentrate
2gm/20 ml
Intas Pharmaceuticals Ltd.
2nd Floor, Chinubhai Centre,
Ashram Road,
Ahmedabad-380009, Gujarat, India
: As per the Prescribing Information o
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to give written informed consent for participation in the trial. 2. Male and female patients between the ages of 18 and 65 years. 3. Patients with Histo-pathologically or through Fine Needle Aspiration Cytology (FNAC) confirmed ï?§ Locally Advanced (non-resectable Stage II or Stage III) or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Gemcitabine as first line treatment) â??ORâ?? ï?§ Pancreatic cancer patients previously treated with 5-Fluorouracil â??ORâ?? ï?§ Advanced Ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy (Gemcitabine in combination with Carboplatin) 4. Recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 5. Patients if already on Radiotherapy, a gap of at least one week shall be maintained between the last day of radiotherapy and the day of screening 6. Patients with life expectancy of at least 2 months 7. Able to comply with study requirement in opinion of Principal Investigator. 8. Adequate hepatic, renal and hematopoietic function.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to Gemcitabine and any ingredient of the formulation. 2. Use of any recreational drugs or history of drug addiction. 3. History of psychiatric disorders. 4. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies. 5. Known case of HIV infection. 6. Pregnant or breast-feeding women. 7. The receipt of an investigational drug or product, or participation in a drug research study within a period of 60 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile of the sponsorâ??s test formulation relative to that of reference formulation in patients and to assess the bioequivalenceTimepoint: Day 7 of the patients PK analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product.Timepoint: up to 30 days afgter last study drug administration | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Ltd
Outcome results
None listed