Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03746912
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-04-15
First Post:
2018-11-15
Brief Title:
Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia AML to Receive Quizartinib
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
An Open-Label Multi-Center Expanded Treatment Protocol of Quizartinib in Adult Subjects With Relapsed or Refractory Acute Myeloid Leukemia AML With FLT3-ITD Mutations
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An expanded access program EAP
Allows doctors to give medicine to patients
Before it is approved by health authorities
This EAP is for
Quizartinib
Patients with FLT3-ITD mutated AML
AML that has come back or
Is resistant to other therapies
A participant will receive quizartinib if
The doctor submits a request
The participant is eligible and
The country allows the EAP
Allows doctors to give medicine to patients
Before it is approved by health authorities
This EAP is for
Quizartinib
Patients with FLT3-ITD mutated AML
AML that has come back or
Is resistant to other therapies
A participant will receive quizartinib if
The doctor submits a request
The participant is eligible and
The country allows the EAP
Detailed Description:
This is an expanded access program EAP providing access to quizartinib for participants with RelapsedRefractory FLT3-ITD mutated AML prior to approval by local regulatory agencies Availability of the EAP is dependent upon physician request country eligibility and localcountry regulations EAP countries included Austria Belgium Brazil Denmark France Germany Ireland Italy Netherlands Norway South Korea Spain Sweden Switzerland Taiwan Thailand United Kingdom and United States Physicians may request access to the EAP for participants who they feel may benefit from quizartinib and meet the eligibility criteria
Participants may continue quizartinib until there is a lack of clinical benefit or the occurrence of unacceptable toxicity Treatment should be interrupted for allogeneic hematopoietic stem cell transplantation HSCT but may be resumed after the transplant
Participant enrollment may continue until 18 months after regulatory approval depending on country regulation or until such time the marketed medication is available whichever occurs first
Participants will be asked to follow the care as outlined by their treating physician Participants will be followed for 30 days after their final treatment or until the patient is transitioned to commercially available product Physicians will be required to report safety data to Daiichi-Sankyo Inc
Quizartinib is currently under development for the treatment of patients 18 years of age or older with relapsed including after HSCT or refractory FLT3-ITD mutated AML and has been granted Fast Track Status in the US and an Orphan Drug Indication in the United States Europe and Asia
Participants may continue quizartinib until there is a lack of clinical benefit or the occurrence of unacceptable toxicity Treatment should be interrupted for allogeneic hematopoietic stem cell transplantation HSCT but may be resumed after the transplant
Participant enrollment may continue until 18 months after regulatory approval depending on country regulation or until such time the marketed medication is available whichever occurs first
Participants will be asked to follow the care as outlined by their treating physician Participants will be followed for 30 days after their final treatment or until the patient is transitioned to commercially available product Physicians will be required to report safety data to Daiichi-Sankyo Inc
Quizartinib is currently under development for the treatment of patients 18 years of age or older with relapsed including after HSCT or refractory FLT3-ITD mutated AML and has been granted Fast Track Status in the US and an Orphan Drug Indication in the United States Europe and Asia
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