Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
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|ClinicalTrials.gov Identifier: NCT03245424|
Expanded Access Status : Approved for marketing
First Posted : August 10, 2017
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia Relapsed Adult AML Relapsed Pediatric AML||Drug: ivosidenib (AG-120)|
Patients who are eligible for enrollment will be entered into the study. Patients will receive ivosidenib 500 mg by mouth once daily on 28-day cycles until disease progression, unacceptable toxicity, physician or subject decision to discontinue, the subject proceeds to hematopoietic stem cell transplant, the subject dies, or until the study closes. Patients who achieve complete remission, undergo stem cell transplant, and then relapse can come back onto the study after consultation with the Medical Monitor. Enrollment into the study will close should ivosidenib be granted marketing authorization. If the study terminates for other reasons, access to drug will be assessed based on the rationale for termination.
All patients will have baseline assessments performed to confirm eligibility. Thereafter, treatment and assessments will be per routine standard of care at the investigational site and documentation will be maintained at the study site in the patient chart. Should study drug be discontinued, it is recommended that the patient return at least 28 days after receiving the last dose of study drug for a safety evaluation.
Safety assessments should be performed at intervals per institutional standard of care for patients taking ivosidenib. These assessments should include, but are not limited to: pregnancy tests, ECG, clinical lab assessments, vital signs and physical exam findings, and assessment of adverse events of special interest (AESIs)/serious adverse events (SAEs). Toxicity severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|Official Title:||Expanded Access Program for Ivosidenib (AG-120) Monotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation|
- Drug: ivosidenib (AG-120)
Patients will receive ivosidenib 500 mg by mouth once daily on 28-day cycles