Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib
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|ClinicalTrials.gov Identifier: NCT03746912|
Expanded Access Status : Available
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Quizartinib is an experimental product being developed by Daiichi Sankyo that has not been approved yet by the FDA for relapsed or refractory FLT3-ITD mutated AML.
The main objective of this program is to provide treatment with quizartinib as monotherapy to patients with relapsed or refractory FLT3-ITD mutated AML who are not eligible to participate in our current clinical trials.
Expanded access treatment with quizartinib as monotherapy is currently available in the United States only, and will consist of 28-day continuous cycles.
However, treatment may be placed on hold or permanently discontinued by the Sponsor at any point for reasons not limited to drug supply shortage, marketing authorization decline, or safety concerns.
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia With Gene Mutations||Drug: Quizartinib Dihydrochloride|
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.
Patients will be asked to follow standard of care as outlined by their treating physician. Patients will be followed for 30 days after their final treatment or until the patient is transitioned to commercially available product. Sites 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 US and Europe.
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|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|
- Drug: Quizartinib Dihydrochloride
Tablets for once daily oral administration at doctor-recommended dose in continuous 28-day cyclesOther Name: Quizartinib
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746912
|Contact: Chiltern/Covance Project Manager||Please use email||QuizartinibEAP@covance.com|