Tratamiento de primera línea con AS703026 en combinación con gemcitabina del cáncer metastático de páncreas y /o tratamiento de segunda línea con AS703026 tras progresión con monoterapia de gemcitabina. MedDRA version: 9 Level: LLT Classification code 10033577 Term: Pancreas carcinoma recurrent MedDRA version: 9 Level: LLT Classification code 10033576 Term: Pancreas carcinoma
Conditions
Interventions
Product Name: MEK inhibitor
Product Code: AS703026
Pharmaceutical Form: Capsule*
Current Sponsor code: AS703026
Concentration unit: mCi/mg millicurie(s)/milligram
Concentration type: equal
Concentrati
Sponsors
Merck Serono S.A. - Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject fully understands requirements of the trial, is willing to comply with all trial visits and assessments, has provided written informed consent. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas and availability of tumor sample (archived or fresh biopsy). Evidence of disease (not necessarily measurable disease) as per complete tumor assessment performed within 28 days prior to trial entry/randomization. Age 18 years and older. Women of childbearing potential must have a negative blood pregnancy test at the screening visit. Willingness to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to, during and four weeks after the last dose trial medication as applicable. 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: Bone marrow impairment as evidenced by hemoglobin 1.5 x upper limit of normal (ULN), and/or calculated creatinine clearance 1.5 x ULN, or AST/ALT > 2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN. Serum calcium > 1 x ULN. History of central nervous system (CNS) metastases, unless certain prerequisites are met. History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product. Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1. Known HIV positivity, active hepatitis C, active hepatitis B or signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. Prior chemotherapy, other than allowed Extensive prior radiotherapy or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed under certain circumstances. History of any other significant medical disease that might impair the subjects well being or preclude full participation in the trial. Significant cardiac conduction abnormalities and/or pacemaker. Pregnant or nursing female subject. Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis or history of retinal vein occlusion. Known hypersensitivity to the AS703026 or gemcitabine. Participation in another clinical trial within the past 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To determine the safety and tolerability of AS703026 combined to gemcitabine in subjects with metastatic pancreatic cancer. To evaluate the anti-tumor activity in each treatment arm in terms of response rate, clinical benefit, overall survival and time to progression. To assess: - the pharmacokinetics (PK) of AS703026 and gemcitabine when given in combination, in subjects with metastatic pancreatic cancer. - changes in pharmacodynamic (Pd) markers (e.g. phospho-ERK in PBMCs).;Primary end point(s): Progression-Free Survival (PFS), defined as time (in months) from randomization date to date of progression prior to the start of subsequent AS703026 monotherapy, as reported and documented by the Investigator (i.e. radiological progression per RECIST criteria). The PFS Hazard Ratio (HR) of experimental arm versus control arm will be used in the primary statistical analysis of the main study part. During the safety run-in: Dose-Limiting Toxicity (DLT) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.;Main Objective: To evaluate the anti-tumor activity of AS703026 combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma. During the safety run-in the Maximum Tolerated Dose (MTD) and the recommended dose of AS703026 when combined with gemcitabine in subjects with metastatic pancreatic adenocarcinoma will be determined. | — |
Countries
Belgium, France, Germany, Spain, United Kingdom
Outcome results
None listed