A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
NCT ID: NCT02422589
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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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2015-10-23
2017-12-12
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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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ceritinib
ceritinib
warfarin
midazolam
Interventions
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ceritinib
warfarin
midazolam
Eligibility Criteria
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Inclusion Criteria
* The test to confirm ALK-positivity may be performed in archival tumor (obtained at or since the time of diagnosis), or in a newly obtained tumor sample taken prior to the first day of study drug. Results confirming ALK-positive status must be available before initiating treatment with ceritinib.
* Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03) prior to starting study drug. Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, nail changes or skin changes are allowed to enter the study.
* Patients who have been treated with chemotherapy, with biological therapy or other investigational agent must have discontinued the treatment at least 2 weeks (14 days) prior to starting the study drug on Study Day 1.In case last chemotherapy contained nitrosourea or mitomycin C, the treatment was discontinued at least 6 weeks prior to starting study drug.
* Patient has the ability to understand and provide signed informed consent.
Exclusion Criteria
* History of carcinomatous meningitis.
* Presence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
* Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:
* Unstable angina within 6 months prior to screening.
* Myocardial infarction within 6 months prior to screening.
* History of documented congestive heart failure (New York Heart Association functional classification III-IV).
* Uncontrolled hypertension defined by a Systolic Blood Pressure ≥ 160 mmHg and/or Diastolic Blood Pressure ≥ 100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication (s) was allowed prior to screening.
* Ventricular arrhythmias.
* Supraventricular and nodal arrhythmias not controlled with medication.
* Other cardiac arrhythmia not controlled with medication.
* Corrected QT (QTcF) \> 470 ms using Fridericia's correction on the screening electrocardiogram (ECG) (as mean of triplicate ECGs).
* Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without anti-hypertensive medication.
* Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
Other Protocol defined Inclusion/Exclusion may applied.
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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Karmanos Cancer Institute Oncology Department
Detroit, Michigan, United States
Henry Ford Hospital SC
Detroit, Michigan, United States
Cancer Therapy & Research Center UT Health Science Center SC-4
San Antonio, Texas, United States
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
A Coruña, Galicia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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Related Links
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Results for CLDK378A2103 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2014-003741-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDK378A2103
Identifier Type: -
Identifier Source: org_study_id