Phase II randomized trial of MEK inhibitor AS703026 or placebo combined with gemcitabine in chemo-naïve metastatic pancreas cancer subjects

Phase 1

• Conditions: First line treatment of metastatic pancreas CA with AS703026 in combination with gemcitabine and / or after progression under gemcitabine monotherapy second line treatment with AS703026.; MedDRA version: 9.1Level: LLTClassification code 10033576Term: Pancreas carcinoma; MedDRA version: 9.1Level: LLTClassification code 10033577Term: Pancreas carcinoma recurrent

• Registration Number: EUCTR2009-011992-61-FR
• Lead Sponsor: Merck Serono S.A. - Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-04
• Study Completion: 2015-02-19
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 141

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

Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 10^9/L, platelets < 100 x 10^9/L.
Renal impairment as evidenced by serum creatinine > 1.5 x upper limit of normal (ULN), and/or calculated creatinine clearance < 60 mL/min.
Liver function abnormality as defined by total bilirubin > 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.

Study & Design

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