Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified
Conditions
Interventions
Intervention1: RX-0201: Dose : 250 mg/msquare/day
Duration : Continuous IV infusion for 14 days followed by 7 days of rest ( 1 Cycle duration is 21 days)
Control Intervention1: Gemcitabine: Dose : 100
Sponsors
Rexahn Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who: 1. Provide written informed consent prior to the initiation of study procedures. 2. Are greater than 18 years of age 3. Have metastatic pancreatic cancer. 4. Have at least a measurable lesion by RECIST criteria. 5. Have a Karnofsky Performance Status of greater than 70. 6. Have at least a 6-month life expectancy as assessed by the investigator. 7. Pre-menopausal women must be surgically sterile or agree to use an accepted method of birth control while participating in the study and for 30 days following the last exposure of study drug. Acceptable forms of birth control are: hormonal contraceptives (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or diaphragm with spermicide), and intrauterine device (IUD). 8. Male subjects need to either be surgically sterile or agree to use a barrier method of birth control described above during the study and for 30 days following the last exposure to study drug. The agreed method of birth control by sunject will be discussed and documented in the source document of subject during the screening phase of the study.
Exclusion criteria
Exclusion criteria: Subjects who: 1. Are unwilling or unable to provide informed consent. 2. Are unwilling or unable to comply with the requirements of the protocol. 3. Have been treated with another investigational agent. 4. Have any of the following screening laboratory values: i. Hemoglobin less than 8.0 grams/deciliter (g/dL) ii. Absolute neutrophil count (ANC) less than 1500/microliter iii. Platelet count less than 100,000/microL iv. Serum creatinine greater than 1.5 x the institutional upper limit of normal (IULN) creatinine. v. Serum bilirubin greater than 1.5 X IULN vi. Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) greater than 2 x IULN (greater than 5 x IULN in presence of known liver metastasis) vii. Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) greater than 2 x IULN (greater than 5 x IULN in presence of known liver metastasis) viii. Have a prothrombin time greater than 1.25 x IULN on screening laboratory assessments. ix. Lack Lewis antigens x. HCV, and HBsAg positive Subjects xi. CA 19-9 less than 75 U/ml 5. Have received either warfarin or heparin treatment within 21 days before Day 1 (the first day of dosing; except for line dose of prophylactic warfarin or heparin). 6. Have a history of brain cancer (primary or metastatic). 7. Have a history of an active hematologic malignancy within the past 2 years. 8. Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV). 9. Have a serious infection requiring intravenous antibiotic therapy during screening. 10. Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tolerability 2. SurvivalTimepoint: 1. At Every Cycle (14 day cycle). 2. At 2,4 & 6 months from the last completed cycle.;1. Tolerability 2. SurvivalTimepoint: 1. At Every Cycle (14 day cycle). 2. At 2,4 & 6 months from the last completed cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular Markers (VEGF, AKT and CA 19-9)Timepoint: NIL;Response(Assessed by RECIST)Timepoint: NIL;Toxicity/ Safety using CTCAE v. 3.0 (safety) and Vital Signs, ECG, Clinical Laboratory Assessment (Safety)Timepoint: NIL | — |
Countries
India, United States of America
Contacts
Public ContactDr Shubhangi Desai
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed