Locally advanced or metastatic pancreatic cancer
Conditions
Interventions
Product Name: Theraloc
Product Code: OSAG 101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nimotuzumab
Current Sponsor code: HR3
Concentration unit: mg/ml milligram(
Sponsors
Oncoscience AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study: 1. written informed consent 2. histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery. 3. measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter = 20 mm using conventional techniques or = 10 mm using spiral computed tomography [CT] scan). 4. able to take medications orally. 5. at least18 years of age or older. 6. Karnofsky Performance Status (KPS) = 70% (see Appendix A). 7. life expectancy of = 12 weeks. 8. adequate organ function as defined by the following criteria: o Transaminases AST (SGOT) and ALT (SGPT) = 2.5 times the upper limit of normal (ULN). o If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be = 5 times ULN. o Total serum bilirubin = 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be = 5 times ULN). o Absolute granulocyte count = 1,500/mm3 (ie, = 1.5 x 10^9/L by International Units [IU]). o Platelet count = 100,000/mm3 (IU: = 100 x 10^9/L). o Hemoglobin value = 9.0 g/dL. o Calculated creatinine clearance = 60 mL/min (based on serum creatinine) (Cockcroft-Gault formula). 9. willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 10. both female and male patients must use adequate methods of contraception. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed: 1. had treatment with any of the following within the specified time frame prior to study drug administration: a. Any prior anticancer chemotherapy. b. Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease). c. Any radiotherapy within the previous 3 weeks. d. Any investigational agent received either concurrently or within the last 30 days. e. Current enrollment in another clinical trial. 2. Major surgery within the previous 3 weeks. 3. Symptomatic brain metastasis not controlled by corticosteroids. 4. Leptomeningeal metastasis. 5. Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer. 6. Uncontrolled ascites requiring drainage at least twice a week. 7. Other serious illness or medical condition(s) including, but not limited to, the following: o - Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class III or IV, see Appendix F), angina pectoris, arrhythmias, or hypertension. o - Active infection. o - Known (at time of entry) gastrointestinal disorder, including malabsorption, chronic nausea, vomiting, or diarrhea, present to the extent that it might interfere with oral intake and absorption of study medication. o - Poorly controlled diabetes mellitus. - Psychiatric disorder that may interfere with consent and/or protocol compliance. - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study. 8. pregnant or lactating female. 9. known hypersensitivity to Anti-EGFR antibodies. 10. with reproductive potential who refuses to use an adequate means of contraception (including male patients). 11. has been treated with gemcitabine in an adjuvant situation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antitumor activity of Nimotuzumab, as assessed by time to tumor progression (TTP) and overall survival (OS) in chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer To assess the efficacy of Nimotuzumab as add on therapy to Gemcitabine in comparison with Gemcitabine and placebo ;Secondary Objective: To evaluate the objective tumor response (overall response rate [ORR]) of Nimotuzumab in combination with Gemcitabine, and duration of response (DR) To evaluate the safety profile of Nimotuzumab in combination with Gemcitabine To evaluate quality of life (QoL) according to EORTC ;Primary end point(s): Design and analysis of this study distinguishes primary and secondary endpoints corresponding to the primary and secondary aims of the study. Confirmatory statistical analyses are solely based on primary endpoints. The primary aim of this comparative phase IIb/IIIa trial is to evaluate the antitumor activity, as assessed by time to tumor progression (TTP), and overall survival (OS) in chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer. For this proof of efficacy of Nimotuzumab (OSAG101, Theraloc?) we examine two primary endpoints: (i) Time to Progression (TTP) (ii) Overall Survival (OS) The primary endpoint OS is taken as responsible endpoint for the determination of the study’s sample size calculation. The primary endpoint TTP is assessed for its power but does not determine the sample size. As we will see later TTP has a higher power than OS in this set up. Time to Tumor Progression (TTP) The primary endpoint TTP is measured from date of randomization to the occurrence of progression or death if that can not be excluded to be related to progression or last date of observation without progression (censored) or death when relation to progression can be excluded (censored). Patients who receive non-study antitumor therapy later on, but before disease progression will be censored | — |
Countries
Germany
Outcome results
None listed