Health Condition 1: null- Metastatic Adenocarcinoma of the Pancreas after Disease Progression Following Gemcitabine-based Therapy
Conditions
Interventions
Intervention1: Irinotecan Liposome Injection, 43 mg/vial: During each of the study periods, patients will receive a single dose (70 mg/m2), administered by intravenous infusion over 90±5 minutes. Cal
Sponsors
Actavis Inc USA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 65 years (both inclusive). 2. Patients with confirmed diagnosis of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy for which FOLFIRI (5FU+Leucovorin+Irinotecan) therapy is indicated. 3. Having a Body Mass Index (BMI) of at least 17 calculated as weight in kg / height in m2. 4. Have an ECOG PS (Eastern Cooperative Oncology Group performance status) of 0, 1 or 2,inclusively. 5. Patients with life expectancy of at least 3 months as judged by the investigator. 6. No clinically significant abnormal laboratory values and adequate Haematology, Renal and Liver function. 7. Able to understand the investigational nature of this study and give written informed consent prior to participation in the trial. 8. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 9. 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] sexual partner) for at least 3 months prior to study drug administration, during study and up to 30 days after the last dose of study drug. 10. For male patients, one of the following must apply in order to avoid impregnating a female partner, from the first study dose until at least 4 months after last dose: • Abstinence • Use of barrier method with spermicide 11. Able to comply with study requirement in opinion of Principal Investigator.
Exclusion criteria
Exclusion criteria: 1. Any clinically significant medical condition or any uncontrolled medical condition that in the opinion of the investigator would preclude safe administration of the study drug or compromise the integrity of the study results. 2. Patients with positive HIV, HBV, HCV and/or VDRL/RPR. 3. Patients with known hypersensitivity or idiosyncratic reaction to the study drug or any related drug. 4. Pregnant or breast feeding women. 5. Previously treated with Irinotecan within 2 weeks, or had chemotherapy within 4 weeks or had radiotherapy within 4 weeks prior to the start of first IP infusion in the study or any investigational drug product within 4 weeks prior to first dose of investigational product (based on half-life of drug). 6. Presence of significant gastrointestinal disorder that predispose the patients to uncontrolled diarrhoea. 7. Patients who had a significant surgery within 4 weeks prior to enrolment in the study. 8. Patients having metastatic disease involving the central nervous system. 9. History of consumption of excessive amounts of alcohol or use of any recreational drugs or history of drug addiction. 10. Positive result of urine screen for drugs of abuse (i.e., Amphetamines, Morphine, Benzodiazepines, Marijuana (THC), Cocaine and Barbiturates). 11. Patient who had donated /or had loss of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose for the study. 12. Patient with bowel obstruction, dyspnoea, cough and fever. 13. Patients homozygous for UGT1A1x28 allele will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence between Test product (Irinotecan liposome injection) and Reference product (ONIVYDEâ?¢ )Timepoint: Patient participation will last for approximately 59 days Clinical Evaluations will be performed at- Visit 1: Screening (Day -14 to Day 0) Visit 2: Period-I (Day 0 and Day 1 to 7) Visit 3: Period-II (Day 0 and Day 1 to 7) Visit 4: Period-III (Day 0 and Day 1 to 7) Visit 5: End of Study (Day 14 after period III dosing) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To monitor safety 2. To determine other pharmacokinetic data 3. To determine pharmacokinetic data for metaboliteTimepoint: Patient participation will last for approximately 59 days Clinical Evaluations will be performed at- Visit 1: Screening (Day -14 to Day 0) Visit 2: Period-I (Day 0 and Day 1 to 7) Visit 3: Period-II (Day 0 and Day 1 to 7) Visit 4: Period-III (Day 0 and Day 1 to 7) Visit 5: End of Study (Day 14 after period III dosing) | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Watson Pharma Pvt. Ltd
Outcome results
None listed