Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis
NCT ID: NCT02370706
Last Updated: 2022-02-09
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
15 participants
INTERVENTIONAL
2015-05-21
2020-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Dose Escalation Arm 1
PIM447
pan-pim inhibitor
Ruxolitinib
JAK1/JAK2 inhibitor
Dose Escalation Arm 2
Ruxolitinib
JAK1/JAK2 inhibitor
LEE011
CDK4/6 inhibitor
Dose Escalation Arm 3
PIM447
pan-pim inhibitor
Ruxolitinib
JAK1/JAK2 inhibitor
LEE011
CDK4/6 inhibitor
Dose Expansion Arm 1
PIM447
pan-pim inhibitor
Ruxolitinib
JAK1/JAK2 inhibitor
Dose Expansion Arm 2
Ruxolitinib
JAK1/JAK2 inhibitor
LEE011
CDK4/6 inhibitor
Dose Expansion Arm 3
PIM447
pan-pim inhibitor
Ruxolitinib
JAK1/JAK2 inhibitor
LEE011
CDK4/6 inhibitor
Interventions
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PIM447
pan-pim inhibitor
Ruxolitinib
JAK1/JAK2 inhibitor
LEE011
CDK4/6 inhibitor
Eligibility Criteria
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Inclusion Criteria
* Patient must be diagnosed with JAK2V617F-positive primary or secondary MF.
* Dose-escalation and Expansion parts: Patients with a \< 35% reduction in spleen volume by MRI/CT or \< 50% reduction in spleen size by physical exam, with or without corresponding symptomatic improvement, after at least 6 months of treatment with single agent ruxolitinib at an optimal dose level in line with the label recommendations. Expansion parts only: Ruxolitinib-naive patients and patients who have been previously treated with single agent ruxolitinib and are relapsed and/or refractory.
* Patients must have splenomegaly measuring at least 5 cm by MRI at baseline.
* Have adequate bone marrow function:
* Platelets ≥ 100,000 mm3 without the assistance of growth factors or platelet transfusions
* Absolute Neutrophil Count (ANC) ≥ 1500/mm3 without growth factor support within 7 days prior to testing
* Hemoglobin ≥ 9 g/dL.
Exclusion Criteria
* Major surgery within 2 weeks before the first dose of either study drug.
* Patients who have had splenic irradiation within 2 weeks prior to Screening or prior splenectomy.
* Patients with AML, MDS, or peripheral blasts ≥ 10 %
* Prior autologous or allogeneic stem cell transplant at any time.
* Patients who are currently receiving treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment:
* substrates of CYP3A4/5, CYP2B6 or CYP2D6 that have a narrow therapeutic window
* strong inhibitors of CYP3A4/5 or CYP2D6
* potent inducers of CYP3A4/5 or CYP2D6
* Serum total bilirubin \> 1.5 x upper limit of normal (ULN) except in patients with Gilbert's syndrome who are excluded if the total bilirubin is \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN, or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or ALT (SGPT) \> 3 x ULN, except in patients with MF involvement of the liver who are excluded if AST or ALT \> 5 x ULN.
* Serum creatinine \> 1.5 x ULN or calculated creatinine clearance \< 60 ml/min according to Cockcroft-Gault equation
* Electrolyte abnormalities CTCAE grade ≥ 2 (e.g. serum potassium, magnesium and calcium) unless they can be repleted during screening and are deemed not clinically significant by the Investigator.
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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Novartis Investigative Site
VIC, Melbourne, Australia
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
London, , United Kingdom
Countries
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Related Links
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Results for CPIM447X2104C can be found on the Novartis Clinical Trial Results Website.
Other Identifiers
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2014-003801-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CPIM447X2104C
Identifier Type: -
Identifier Source: org_study_id
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