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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COMPLETED
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2014-10-07
2019-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lapatinib + trametinib
lapatinib: oral tablets, once daily trametinib: oral tablets, once daily
Lapatinib
trametinib
Interventions
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Lapatinib
trametinib
Eligibility Criteria
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Inclusion Criteria
* Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
* Age ≥ 18 years
* Able and willing to give written informed consent
* WHO performance status of 0 or 1 (part A and B)
Exclusion Criteria
* History of another primary malignancy
* Symptomatic or untreated leptomeningeal disease
* Symptomatic brain metastasis
* History of interstitial lung disease or pneumonitis
* Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
* Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
* Patients with left ventricular ejection fraction (LVEF) \< 50%
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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F Opdam, MD, PhD
Role: STUDY_DIRECTOR
The Netherlands Cancer Institute
Locations
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The Netherlands Cancer Institute
Amsterdam, , Netherlands
Countries
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Other Identifiers
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NL49551.031.14
Identifier Type: -
Identifier Source: org_study_id
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