A study to assess the efficacy and safety of ON 01910.Na in combination with Gemcitabine vs. Gemcitabine alone in patients with a previously untreated metastatic pancreatic cancer.

• Conditions: Metastatic Pancreatic Cancer; MedDRA version: 15.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003547-29-HU
• Lead Sponsor: Onconova Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-25
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

1. 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;
2. Patients must have received no prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy;
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 (see Appendix 1);
5. Patients must have adequate renal function and serum creatinine =2.0 mg/dL, with a minimum calculated glomerular filtration rate (GFR) of 40 mL/min (Cockcroft-Gault method);
6. Patients must have adequate liver function as defined by total bilirubin = 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;
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 (ßHCG) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 346

Exclusion Criteria

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, uncontrolled 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 radiotherapy, or immunotherapy;
11. 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.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified