Ignite Creation Date:
2024-05-06 @ 3:41 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02343679
Status:
WITHDRAWN
Last Update Posted:
2017-02-01
First Post:
2014-12-03
Brief Title:
Novartis PhII Ceritinib LDK378 in RR ALK Hem Malignancies
Sponsor:
Anne Beaven MD
Organization:
Duke University
Study Overview
Official Title:
A Phase II Study of the ALK Inhibitor Ceritinib LDK378 in RelapsedRefractory ALK Hematologic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No accrual due to rarity of disease
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II single arm unblinded study of ceritinib in patients with relref hematologic malignancies Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled Any subject who takes at least one dose of study drug will be evaluable for safety Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response Each subject will receive the same dose of 750mg po daily at the study entry Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision Intrapatient dose reductions will be allowed for adverse events This is a multicenter study with Duke as the lead site Blood and tissue samples will be collected and used for exploratory analysis
Detailed Description:
This is a phase II single arm unblinded study of ceritinib in patients with relref hematologic malignancies Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled Any subject who takes at least on dose of study drug will be evaluable for safety Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response Each subject will receive the same dose of 750mg po daily at the study entry Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision Intrapatient dose reductions will be allowed for adverse events Blood and tissue samples will be collected and used for exploratory analysis
Dose Level 0 starting dose 750mgday Dose level -1 600mgday Dose level -2 450mgday
Baseline evaluations are to be conducted within 30 days prior to start of protocol therapy unless otherwise noted in the time to events table Scans and x-rays must be performed within six weeks prior to the start of therapy Bone marrow biopsy must be performed within twelve weeks prior to starting therapy In the event that the patients condition is deteriorating laboratory evaluations should be repeated within 48 hours prior to initiation of the next cycle of therapy All the labs have to be within the study eligibility range prior to the start of study treatment
All visits should occur within 3 days before or after the scheduled day of the visit An early or late visit will not shorten or extend the duration of that cycle - all cycles will be 28 days
If study drug is held for any reason then the missed days should still be counted as a day in the cycle However if the study drug is on hold when a 28 day cycle ends then day 1 of the next cycle and the necessary evaluations should not be started until drug is restarted Therefore the cycle during which a drug is held could potentially have more than 28 days
Patients will be followed for up to 2 years after completion of therapy or until progression of disease or death whichever comes first In follow up patients will be seen every 3 months for physical exam lab draws for the first two years after completing all study drugs or until alternative therapy is begun or until progression of disease or death-whichever comes first Radiographic imaging will be performed every 6 months for the first two years after study drug is completed
Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event and will continue to be followed until progression of disease or death Unacceptable adverse events are those that lead to stopping of a study drug and for which there is no resolution of drug related toxicity after a 6 week washout period so that the subject is removed from study as defined in section 6
Patients removed from the study due to progressive disease will be followed until resolution or stabilization of any adverse events due to the agents after which their follow up will be completed
At a minimum all patients who discontinue ceritinib treatment including those who refuse to return for a final visit will be contacted for safety evaluations during the 30 days following the last dose of treatment
Dose Level 0 starting dose 750mgday Dose level -1 600mgday Dose level -2 450mgday
Baseline evaluations are to be conducted within 30 days prior to start of protocol therapy unless otherwise noted in the time to events table Scans and x-rays must be performed within six weeks prior to the start of therapy Bone marrow biopsy must be performed within twelve weeks prior to starting therapy In the event that the patients condition is deteriorating laboratory evaluations should be repeated within 48 hours prior to initiation of the next cycle of therapy All the labs have to be within the study eligibility range prior to the start of study treatment
All visits should occur within 3 days before or after the scheduled day of the visit An early or late visit will not shorten or extend the duration of that cycle - all cycles will be 28 days
If study drug is held for any reason then the missed days should still be counted as a day in the cycle However if the study drug is on hold when a 28 day cycle ends then day 1 of the next cycle and the necessary evaluations should not be started until drug is restarted Therefore the cycle during which a drug is held could potentially have more than 28 days
Patients will be followed for up to 2 years after completion of therapy or until progression of disease or death whichever comes first In follow up patients will be seen every 3 months for physical exam lab draws for the first two years after completing all study drugs or until alternative therapy is begun or until progression of disease or death-whichever comes first Radiographic imaging will be performed every 6 months for the first two years after study drug is completed
Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event and will continue to be followed until progression of disease or death Unacceptable adverse events are those that lead to stopping of a study drug and for which there is no resolution of drug related toxicity after a 6 week washout period so that the subject is removed from study as defined in section 6
Patients removed from the study due to progressive disease will be followed until resolution or stabilization of any adverse events due to the agents after which their follow up will be completed
At a minimum all patients who discontinue ceritinib treatment including those who refuse to return for a final visit will be contacted for safety evaluations during the 30 days following the last dose of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None