Advanced pancreatic adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic
Conditions
Interventions
Product Name: AEG35156
Product Code: AEG35156
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: AEG35156
Curren
Sponsors
Aegera Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically confirmed advanced pancreatic adenocarcinoma who are candidates for first-line gemcitabine therapy Karnofsky performance greater than or equal to 70% One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only) Life expectancy of at least 3 months Age greater than or equal to 18 years Signed, written IRB-approved informed consent A negative serum pregnancy test Acceptable liver function: 1) Total bilirubin less than or equal to 1.5 times the Institution's upper limit of normal (ULN), 2) AST (SGOT) and ALT (SGPT) less than or equal to 2.5 x ULN or less than or equal to 5 x ULN if there are documented liver metastases Acceptable renal function: Serum creatinine within normal limits, OR calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal Acceptable hematologic status: 1) Granulocyte greater than or equal to 1500 cells/microlitre, 2) Platelet count greater than or equal to 100,000 plt/microlitre, 3) Hemoglobin greater than or equal to 9.0 g/dL Acceptable coagulation status: 1) PT within normal limits, 2) PTT within normal limits For women of child-producing potential, the use of effective contraceptive methods during the study Prior radiothrerapy for local disease is allowed provided disease progression has been documented, and treatment completed at least 4 weeks prior to registration. 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: Prior chemotherapy for pancreatic cancer, except for 5-fluorouracil or gemcitabine given as a radiosensitizer. Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions. Known bleeding diathesis or concurrent treatment with anticoagulants except patients on non-therapuetic line mantenance coumadin. Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, hepatitis B, or hepatitis C. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded. Unwillingness or inability to comply with procedures required in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Phase 1: The primary objective of the Phase 1 study is to determine the recommended dose of AEG35156 when used in combination with gemcitabine in patients with advanced pancreatic cancer. This determination will be based upon the development of DLT during the first cycle of therapy, and on pharmacokinetic determination for plasma AEG35156 and gemcitabine,obtained after the first combined administration of the two agents. Phase 2: The Phase 2 is an open label, nonrandomized study. The primary objective of this study is to determine the objective response rate of AEG35156 when used in combination with gemcitabine in advanced pancreatic cancer. This determination will be based on objective tumor responses and progression-free survival. The tumor response will be evaluated at the end of every even numbered cycle (i.e., cycles 2, 4, 6, etc.) according to RECIST Response Criteria and the Choi Criteria. The RECIST Criteria will be used for response statistical analysis. The progression-free survival (PFS) will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease progression (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression. Safety and tolerability, as measured by Grade 3-4 laboratory abnormalities related to study treatment, serious adverse events and adverse events will be assessed during the study through to 28 days post-last dose. ; Main Objective: To determine the recommended dose of AEG35156 when used in combination with gemcitabine. To determine if AEG35156 can enhance the response rate of gemcitabine in patients with advanced pancreatic cancer. ; Secondary Objective: To determine progression-free survival. To establish the pharmacokinetics of AEG35156 and gemcitabine when use | — |
Countries
United Kingdom
Outcome results
None listed