Status and phase
Conditions
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Study type
Funder types
Identifiers
About
In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule, additional patients will be enrolled in the phase II portion of the study at the RP2D on the chosen schedule in order to assess the anti-tumor activity of the combination in addition to continued evaluation of safety.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
Patients enrolled into phase Ib may be enrolled with evaluable disease only. Patients enrolled into the phase II expansion must have at least one measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
Patients must have adequate organ function, as defined by the following parameter
Exclusion criteria
Presence of any brain metastases detected by MRI or CT with i.v. contrast of the brain at screening.
Uncontrolled arterial hypertension despite medical treatment
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Patients who are currently receiving treatment with agents that are known to cause QTc prolongation in humans.
Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) or elevated baseline CK levels (≥ Grade 2)
Patients who are currently receiving treatment with agents that are metabolized predominantly through CYP3A4 and that have a narrow therapeutic window.
Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (i.e. uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
Other protocol related inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
102 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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