An interventional study of the combination of MEK162 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors

Conditions: colorectal adenocarcinoma.metastatic pancreatic adenocarcinomamelanoma
MedDRA version: 16.1Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1Level: PTClassification code 10052360Term: Colorectal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000305-76-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 91

Inclusion Criteria

• Patients aged = 18 years
• Patients with advanced solid tumors (CRC, melanoma) with
documented somatic KRAS or BRAFV600 mutations in tumor tissue.
Patients with metastatic pancreatic adenocarcinoma may be enrolled
irrespectively of KRAS or BRAFV600 mutational status.
• Patients must have relapsed or progressed following standard
or patients for whom no standard anticancer therapy exists.
• Measurable disease as determined by RECIST v1.1. World Health
Organization (WHO) Performance Status (PS) = 2.
• Adequate organ function
• Negative serum pregnancy test
Other protocol-defined inclusion criteria may apply
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 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

• Prior therapy with MEK- or IGF-1R- inhibitor
• History or current evidence of central serous retinopathy (CSR), retinal
vein occlusion (RVO) or retinal degenerative disease
• Patients with known history of severe infusion reactions to monoclonal
antibodies
• Patients with primary CNS tumor or CNS tumor involvement
• History of thromboembolic event requiring full-dose anticoagulation
therapy
• Clinically significant cardiac disease
• History of another malignancy within 2 years
• Pregnant or nursing (lactating) women
Other protocol-defined exclusion criteria may apply