A Study of PLX51107 in Advanced Malignancies
|ClinicalTrials.gov Identifier: NCT02683395|
Recruitment Status : Terminated (Business Decision)
First Posted : February 17, 2016
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Acute Myeloid Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma||Drug: PLX51107||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2a, Two-Part, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects With Advanced Hematological Malignancies and Solid Tumors|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Experimental: Treatment Group A
Open label, sequential PLX51107 dose escalation in approximately 30 solid tumor subjects.
Experimental: Treatment Group B
Open label, sequential PLX51107 dose escalation in approximately 30 subjects with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
- Safety of PLX51107 as measured by adverse events and serious adverse events. [ Time Frame: 1 year ]
- Area under the concentration-time curve (AUC) of PLX51107. [ Time Frame: 1 year ]
- Maximum observed concentration (Cmax) of PLX51107. [ Time Frame: 1 year ]
- Time to peak concentration (Tmax) of PLX51107. [ Time Frame: 1 year ]
- Half life (t1/2) of PLX51107. [ Time Frame: 1 year ]
- Overall Response Rate (ORR) [ Time Frame: 1 year ]ORR is defined as the total number of patients with the best overall response according to standard criteria for the relevant malignancy divided by the total number of treated patients and expressed as a percentage.
- Duration Of Response (DOR). [ Time Frame: 1 year ]DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
- Progression-Free Survival (PFS). [ Time Frame: 1 year ]PFS time is defined as the time from the first dose of PLX51107 to disease progression or death, whichever occurs first.
- Overall Survival (OS). [ Time Frame: 1 year ]OS is defined as the first dose of study drug until the date of death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683395
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|The Ohio State University Stephanie Spielman Comprehensive Breast Center|
|Columbus, Ohio, United States, 43212|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, South Carolina|
|MUSC/ Hollings Cancer Center|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|