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Complete title: A Phase II/III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer
|Research Study Number||20111067|
|Principal Investigator||Andrew Coveler, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients at least 18 years old presenting with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas; metastatic disease is defined as disease which has spread beyond the peri-pancreatic lymph nodes.
- Patients must have received no prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy.
- Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) = to or>20 mm using conventional techniques or = to or>10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be = to or >15 mm in the short axis.
- ECOG Performance Status of 0, 1, or 2.
- Patients must have adequate renal function and serum creatinine = to or < 2.0 mg/dL.
- Patients must have adequate liver function as defined by total bilirubin = to or < 2.0 mg/dL and transaminase levels no higher than 3.0 times the institution's upper limit of normal (ULN). Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN.
- All patients must have a serum albumin = to or >3.0 g/dL.
- Patients must have adequate bone marrow (BM) function as defined by a granulocyte count = to or >1,500/mm3, a platelet count = to or >100,000/mm3, and hemoglobin >9 g/dL.
- 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).
- 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.
- Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin (bHCG) pregnancy test at Screening.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Patient must have signed an informed consent document.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Life expectancy of less than 12 weeks.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or seizure disorder.
- Active infection not adequately responding to appropriate therapy.
- Symptomatic or clinically evident ascites.
- Female patients who are pregnant or lactating.
- Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol.
- Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
- Evidence of brain metastases.
- Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of radiotherapy, or immunotherapy.
- Psychiatric illness/social situations that would limit the patient's 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.).
Other exclusion criteria may apply.
Pancreatic Cancer; Solid Tumors
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