A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
NCT ID: NCT01562899
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
77 participants
INTERVENTIONAL
2012-08-27
2015-04-01
Brief Summary
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Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.
Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Dose escalation
Dose finding group chosen in order to establish a safe and tolerated dose of binimetinib in combination with ganitumab in patients with selected advanced solid tumors.
MEK162
Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
AMG 479
Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
KRAS mutated colorectal adenocarcinoma
Patients with KRAS mutant colorectal cancer.
The starting dose (30 mg bid) of binimetinib chosen for this study was a fraction of the MTD (60 mg bid) and the RP2D (45 mg bid) determined for single agent use. The starting dose for ganitumab was 12 mg/kg q2w which had been shown to be a well-tolerated dose in combination with other anti-cancer agents.
MEK162
Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
AMG 479
Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
Metastatic pancreatic adenocarcinoma
Patients with metastatic pancreatic cancer.
The starting dose (30 mg bid) of binimetinib chosen for this study was a fraction of the MTD (60 mg bid) and the RP2D (45 mg bid) determined for single agent use. The starting dose for ganitumab was 12 mg/kg q2w which had been shown to be a well-tolerated dose in combination with other anti-cancer agents.
MEK162
Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
AMG 479
Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
BRAF mutated melanoma
Patients with mutant BRAF V600 melanoma.
The starting dose (30 mg bid) of binimetinib chosen for this study was a fraction of the MTD (60 mg bid) and the RP2D (45 mg bid) determined for single agent use. The starting dose for ganitumab was 12 mg/kg q2w which had been shown to be a well-tolerated dose in combination with other anti-cancer agents.
MEK162
Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
AMG 479
Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
Interventions
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MEK162
Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
AMG 479
Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 therapy 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Massachusetts General Hospital Mass General 2
Boston, Massachusetts, United States
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, United States
Pfizer Investigative Site
Parkville, Victoria, Australia
Pfizer Investigative Site
Leuven, , Belgium
Pfizer Investigative Site
Toronto, Ontario, Canada
Pfizer Investigative Site
Toulouse, , France
Pfizer Investigative Site
Napoli, , Italy
Pfizer Investigative Site
Barcelona, Catalonia, Spain
Pfizer Investigative Site
Sutton, Surrey, United Kingdom
Countries
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Other Identifiers
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C4211010
Identifier Type: OTHER
Identifier Source: secondary_id
2012-000305-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMEK162X2111
Identifier Type: -
Identifier Source: org_study_id