Individual Patient Expanded Access Gilteritinib (ASP2215)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03315299|
Recruitment Status : Available
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment|
This treatment protocol is being conducted in a single pediatric patient while phase 3 ASP2215 studies are ongoing in adult subjects with FLT3-mutated AML.
The subjects will enter the screening period up to 2 weeks prior to the start of treatment.
The subject will be administered treatment over 28-day cycles.
The subjects will complete visits on cycle 1 days 1, 4, 8, 15; cycle 2 days 1, 15, and day 1 of each cycle thereafter until discontinued from the study for toxicity, disease progression, or lack of continued benefit in the judgement of the investigator.
An end of treatment visit will be performed within 7 days after last dose of the investigation product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow up.
|Study Type :||
|Official Title:||Individual Patient Expanded Access for Use of Gilteritinib (ASP2215) for Patient Y.A.|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315299
|Contact: Etan Orgel, MD MSfirstname.lastname@example.org|
|Contact: Diana Shycoffemail@example.com|
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Contact: Etan Orgel, MD 323-361-2984 firstname.lastname@example.org|
|Contact: Steven Mittelman, MD 323-361-7653 email@example.com|
|Principal Investigator: Etan Orgel, MD|
|Principal Investigator: Steven Mittelman, MD, PhD|