Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma
NCT ID: NCT02144038
Last Updated: 2020-12-17
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
20 participants
INTERVENTIONAL
2014-07-23
2015-10-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase Ib: LGH447 + BYL719
Dose-escalation, LGH447 in combinatinon with BYL719
LGH447
pan-PIM inhibitor
BYL719
PI3K-alpha inhibitor
Phase II: LGH447 + BYL719
LGH447 + BYL719 (dosing according to MTD/RP2D from Phase Ib portion of the study)
LGH447
pan-PIM inhibitor
BYL719
PI3K-alpha inhibitor
Phase II: LGH447 alone
LGH447 alone (dosing according to single-agent RDE)
LGH447
pan-PIM inhibitor
Interventions
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LGH447
pan-PIM inhibitor
BYL719
PI3K-alpha inhibitor
Eligibility Criteria
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Inclusion Criteria
* For patients in the Phase II portion of the study, must have measurable disease defined by at least 1 of the following 3 measurements:
* Serum M-protein ≥ 0.5 g/dL
* Urine M-protein ≥ 200 mg/24 hours OR
* Serum free light chain (FLC) \> 100 mg/L of involved FLC
* All patients must be willing to undergo a mandatory bone marrow aspirate and/or biopsy at baseline for the assessment of biomarker/pharmacodynamics and disease status
Exclusion Criteria
* Radiotherapy within 14 days before the first dose of either study drug except localized radiation therapy for lytic bone lesions and plasmacytomas
* Major surgery within 2 weeks before the first dose of either study drug
* Ongoing therapy with chronic or high dose corticosteroids. Low dose steroids (i.e. prednisone ≤ 10 mg or an equivalent steroid dose), inhaled and topical steroids are permitted
* Patients who are currently receiving treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment:
* Narrow Therapeutic index substrates, strong inhibitors and strong inducers of CYP3A4
* Strong Inhibitors of CYP2D6
* Narrow therapeutic index substrates of CYP2C8, CYP2C9, CYP2C19 and CYP2D6
* Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of either study drug):
* Absolute neutrophil count (ANC) \< 1,000/mm3 without growth factor support within 7 days prior to testing
* Platelet count \< 75,000 mm3 without transfusion support within 7 days prior to testing
* Bilirubin \> 1.5 times the upper limit of the normal range (ULN).
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the ULN.
* Calculated creatinine clearance \< 30 ml/min according to Cockcroft-Gault equation
* Corrected QT interval (QTc) of \> 450 milliseconds (ms) in males and \> 470 milliseconds (ms) in females on baseline electrocardiogram (ECG) (using Fridericia \[QTcF\] corrected QT interval
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(SC)
Houston, Texas, United States
Seattle Cancer Care Alliance Oncology Dept
Seattle, Washington, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Dept of Onc.
Madison, Wisconsin, United States
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Kiel, , Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Singapore, , Singapore
Countries
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Related Links
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Results for CLGH447X2103C can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2013-004959-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLGH447X2103C
Identifier Type: -
Identifier Source: org_study_id