A Study to Find the Maximum Tolerated Dose of the Experimental Combination of the Drugs INC424 and BKM120 in Patients With Primary or Secondary Myelofibrosis
NCT ID: NCT01730248
Last Updated: 2020-12-19
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
63 participants
INTERVENTIONAL
2012-12-18
2017-09-28
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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JAK Inhibitor Naive
Two treatment periods applicable to all patients; Treatment Period (6 cycles / 28 days per cycle) and Extension Period ( 6 or more cycles of 28 days, with visits every 28days for 6 cycles and then visits every 12 weeks) following the treatment period dependent on patient continued eligibility. Two Study Phases: Dose Escalation Phase to determine maximum tolerated dose (MTD) / Recommended Phase II dose (RPIID) \& an Expansion Phase
INC424
5 mg tablets administered orally twice daily
BKM120
10 mg and 50 mg hard gelatin capsules administered orally once daily
Prior JAK Inhibitor
Two treatment periods applicable to all patients; Treatment Period (6 cycles / 28 days per cycle) and Extension Period (6 or more cycles of 28 days, with visits every 28 days for 6 cycles then visits every 12 weeks) following the treatment period dependent on patient continued eligibility. Two Study Phases: Dose Escalation Phase to determine MTD / RPIID \& an Expansion Phase
INC424
5 mg tablets administered orally twice daily
BKM120
10 mg and 50 mg hard gelatin capsules administered orally once daily
Interventions
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INC424
5 mg tablets administered orally twice daily
BKM120
10 mg and 50 mg hard gelatin capsules administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* Myelofibrosis patients requiring therapy must be classified as intermediate risk level 1 )1 or more prognostic factors defined by IWG) with at least one criteria other than age
* Must have palpable spleen of at least 5 cm from the costal margin to the point of greatest splenic profusion at Screening
* Must have active symptoms of MF (one symptom score of at least 5 or two symptom scores of at least 3 at Screening) (per MFSSF 0-10)
* PLT counts \> or = 75X 10\^9/L at Screening or Cycle 1 Day 1 (not with aid of transfusions
Exclusion Criteria
* WOCBP not using highly effective methods of contraception
* Sexually active males who refuse condom use
* Previous Treatment with one of the following: PI3 K inhibitors and AKT inhibitors; JAK inhibitors that resulted in clinically significant toxicities per the Investigator;
* Patients who have had splenic irradiation within 12 months prior to Screening
* Patients with specific mood disorders
* Any history of bleeding diathesis
* Patients receiving the following treatments / medications:
EIAED within 2 wks. prior to study treatment; medication known to prolong QT interval or induce Torsades de Pointes; treatment with potent systemic systemic inhibitor or systemic inducer of CYP3A4; any use of drug that interferes with coagulation or inhibits PLT function
-current and willing candidates for a stem cell transplantation
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
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
Herston, Queensland, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Rostock, , Germany
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Ramat Gan, , Israel
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Varese, VA, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Edgbaston, Birmingham, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Related Links
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Results for INC424A2104 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CINC424A2104
Identifier Type: -
Identifier Source: org_study_id