Health Condition 1: null- Previously Untreated Metastatic Pancreatic Cancer
Conditions
Interventions
Intervention1: Gemcitabine 1000mg/m2 +
ON 01910. Na 1800mg/m2: Gemcitabine 1000mg/m2 weekly for 3 weeks of 4 weeks cycle (on day 1, 8 & 15 of the 4 week cycle)
+
ON 0
Sponsors
Onconova Therapeutics Inc
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients at least 18 years old with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. 2. Patients must have received no prior chemotherapy for pancreatic cancer. 3. Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) >= 20 mm using conventional techniques or >= 10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be >= 15 mm in the short axis. 4. ECOG Performance Status of 0, 1, or 2. 5. Patients must have adequate renal function and serum creatinine 6. Patients must have adequate liver function as defined by total bilirubin 7. All patients must have a serum albumin >= 3.0 g/dL. 8. Patients must have adequate bone marrow (BM) function as defined by a granulocyte count >= 1,500/mm3, a platelet count >= 100,000/mm3, and hemoglobin 9 g/dL. 9. Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease). 10. Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients. Male patients with female partners with reproductive potential will utilize birth control methods (e.g., condom use) while participating in this trial; 11.Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin pregnancy test at Screening. 12.Willing to adhere to the prohibitions and restrictions specified in this protocol. 13.Patient must have signed an informed consent document.
Exclusion criteria
Exclusion criteria: Patients with any of the following will not be enrolled in the study: 1. Patients with unresectable locally advanced disease without evidence of disease elsewhere; 2. Life expectancy of less than 12 weeks; 3. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension or seizure disorder; 4. Active infection not adequately responding to appropriate therapy. 5. Symptomatic or clinically evident ascites. 6. Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia (e.g., previous syndrome of inappropriate antidiuretic hormone hypersecretion [SIADH], chronic diuretic use, etc.) 7. Female patients who are pregnant or lactating. 8. Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start. 9. Evidence of brain metastases. A CT scan or magnetic resonance imaging (MRI) of the brain should be obtained in patients with symptoms suggestive of brain metastases; 10. Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of an investigational agent, chemotherapy, radiotherapy, or immunotherapy. 11. Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Time Timepoint: This is the time from randomization to death of patient from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker analysisTimepoint: At the time of screening;Full ON 01910.Na and gemcitabine pharmacokinetics in a subset of 10 patients in the combined treatment group onlyTimepoint: â?¢predose,i.e.,before starting gemcitabine infusion â?¢15min after starting gemcitabine infusion â?¢30min,immediately before ending gemcitabine infusion â?¢45min after starting ON01910.Na infusion â?¢60min after ON01910.Na infusion start â?¢2hr30min,immediately before ending ON01910.Na infusion â?¢2hr45min, 3hr, 3hr30min, 4hr30min,6hr30min and 10hr30min after ending ON01910.Na infusion;ON 01910.Na Population Pharmacokinetics for all patients in Arm A at pre-dose, 1 hour after starting the ON 01910.Na infusion, and just before the end of the ON 01910.Na infusion Timepoint: On Cycle 1 Day 1 and Cycle 1 Day 15 | — |
Countries
Hungary, India, Romania, Russian Federation, Ukraine, United States of America
Contacts
Public ContactDr Manmohan Acharya
Outcome results
None listed