A Study of PLX2853 in Advanced Malignancies.
|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: NCT03297424|
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer Uveal Melanoma Ovarian Clear Cell Carcinoma Non-Hodgkin Lymphoma Advanced Malignancies Solid Tumor Diffuse Large B Cell Lymphoma Follicular Lymphoma||Drug: PLX2853||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2a Dose-escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX2853 in Subjects With Advanced Malignancies|
|Actual Study Start Date :||September 12, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||May 2021|
Phase 1b (Dose Escalation): Up to 30 Subjects with advanced malignancies.
Phase 2a (Dose Expansion): There will be 5 total expansion cohorts. Either 10 or 29 subjects per cohort in each of 4 expansion cohorts: advanced SCLC, uveal melanoma, OCCC, and any other advanced malignancy with a known ARID1A mutation (between 40 to 116 subjects total for the solid tumor expansion phase). For the 5th expansion cohort, up to 20 subjects may be enrolled for NHL.
Other Name: PLX2853 tablets
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. [ Time Frame: First dose of study drug through at least 30 days after end of treatment. ]
- Area under the concentration-time curve (AUC) of PLX2853. [ Time Frame: From first dose of PLX2853 up to 30 days after end of treatment. ]
- Maximum observed concentration (Cmax) of PLX2853. [ Time Frame: From first dose of PLX2853 up to 30 days after end of treatment. ]
- Time to peak concentration (Tmax) of PLX2853. [ Time Frame: From first dose of PLX2853 up to 30 days after end of treatment. ]
- Half life (t1/2) of PLX2853. [ Time Frame: From first dose of PLX2853 up to 30 days after end of treatment. ]
- Number of participants who experience dose limiting toxicity as defined in the protocol. [ Time Frame: Up to 2 years ]The highest dose level at which less than 2 of 6 participants or less than 33% of participants (if cohort is expanded beyond 6) experience a dose limiting toxicity will be considered the maximum tolerated dose / recommended phase 2 dose.
- Change in disease burden using RECIST 1.1 (solid tumors) or Lugano criteria (NHL). [ Time Frame: Up to 2 years ]
- Overall response rate (ORR) defined according to standard criteria for the relevant malignancy [Phase1b] [ Time Frame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years. ]
- Duration of response (DOR) [ Time Frame: DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first, assessed up to 2 years. ]
- Progression-Free Survival (PFS) [ Time Frame: PFS time is defined as the time from the first dose of PLX2853 to disease progression or death, whichever occurs first, assessed up to 2 years. ]
- Overall Survival (OS) [ Time Frame: From the first dose of study drug until the date of death from any cause, assessed up to 2 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297424
|Contact: Michael Pelayo||510-647-4038||MPelayo@plexxikon.com|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, New York|
|Columbia (Herbert Irving Comprehensive Cancer Center)||Not yet recruiting|
|New York, New York, United States, 10032|
|United States, Texas|
|South Texas Accelerated Research Therapeutics (START)||Recruiting|
|San Antonio, Texas, United States, 78229|