Study of IACS-010759 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This clinical research study has 2 parts: dose escalation and dose expansion.
The goal of dose escalation in this clinical research study is to find the best dose of IACS-010759 that can be given to patients with relapsed or refractory AML.
The goal of dose expansion in this clinical research study is to learn if the dose of IACS-010759 found in the dose escalation part of the study is the best dose to use in future studies using IACS-010759 in patients with AML.
The safety and tolerability of this drug will also be studied.
This is the first study using IACS-010759 in humans.
|Acute Myeloid Leukemia||Drug: IACS-010759 Behavioral: Phone Call Follow Up||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of IACS-010759 in Subjects With Relapsed or Refractory Acute Myeloid|
- Maximum Tolerated Dose (MTD) of IACS-010759 [ Time Frame: 21 days ]
MTD defined as the highest dose studied for which observed incidence of dose limiting toxicity (DLT) is less than 33%. Frequencies of toxicities tabulated according to the NCI Common Toxicity Criteria version 4.03.
DLT defined as a clinically significant non-hematologic adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and is possibly, probably or definitely related to the study drug and occurring during the first cycle.
- Overall Response Rate (ORR) as Determined by Complete Remission (CR), Complete Remission with Incomplete Hematological Recovery (CRi), Partial Remission (PR), Morphologic Leukemia-Free State (MLFS), and Hematologic Improvement (HI): [ Time Frame: 63 days ]Participants undergo bone marrow aspirate and/or biopsy.
|Actual Study Start Date:||September 29, 2016|
|Estimated Study Completion Date:||September 2022|
|Estimated Primary Completion Date:||September 2022 (Final data collection date for primary outcome measure)|
Dose Escalation Phase: IACS-010759 administered orally daily on a 21-day schedule, with the exception that the first cycle for each subject contains a 7-day single dose lead-in. Treatment administered as an inpatient for 24 hours on day 1 and then starting on day 8 for the next 7 days for all enrolled subjects. Starting on day 8 of cycle 1, dosing is on a 21 day schedule until confirmed progressive disease (PD), initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue.
Dose Expansion Phase: Subjects in the expansion phase treated at the RP2D level determined in the dose-escalation phase.
Behavioral: Phone Call Follow Up
Dose Escalation Phase Starting Dose: 0.5 mg by mouth daily on a 21-day schedule.
Dose Expansion Phase Starting Dose: Maximum tolerated dose from Dose Escalation Phase.
If participant's disease appears to be responding to study drug, member of the study staff calls every 3-6 months for up to 5 years.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02882321
|Contact: Marina Konopleva, MD, PHD||713-794-1628|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marina Konopleva, MD, PHD||M.D. Anderson Cancer Center|