A Study of APX3330 in Patients With Advanced Solid Tumors (APX3330)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03375086|
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: APX3330||Phase 1|
Apurinic/apyrimidinic endonuclease 1/redox factor-1 (APE1/Ref-1) is a protein that regulates multiple transcription factors involved in cancer cell signaling and APX3330 is a highly selective inhibitor of APE1/Ref-1 redox function.
The anti-tumor effect of APX330 has been demonstrated in a variety of preclinical models and the human safety profile of APX3330 was established in prior clinical studies. Apexian Pharmaceuticals is developing APX3330 as an orally administered anti-cancer agent targeting the APE1/Ref-1 protein.
APX_CLN_0011 is a Phase 1, multi-center, open-label, dose-escalation oncology study in patients with advanced solid tumors. The study primary objective is to determine the recommended Phase 2 study dose of APX3330. Secondary objectives include assessment of APX3330 safety, anti-tumor activity, pharmacokinetic and pharmacodynamic profile.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, multi-center, dose escalation.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of APX3330 in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||January 30, 2018|
|Actual Primary Completion Date :||August 18, 2018|
|Actual Study Completion Date :||January 9, 2019|
Experimental: Single arm
Patients will receive APX3330 orally, twice per day until disease progression
APX3330 will be supplied as 60 and 120 mg orally administered tablets. Patients will receive a fixed dose of APX3330 twice daily (i.e., bid) each day of a 21-day cycle. The starting dose of APX3330 will be a daily dose of 240 mg (i.e., 120 mg/dose bid). Doses will be increased until identification of a maximum tolerated dose or bio-effective dose, whichever is lower.
Other Name: E3330
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 12 months ]Identification of the safety and tolerability of APX3330
- Any anti-tumor activity that may occur in patients receiving APX3330 using RECIST criteria [ Time Frame: 18 months ]Using RECIST criteria
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): NCT03375086
|United States, Indiana|
|Indiana University Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49546|
|United States, Texas|
|START San Antonio|
|San Antonio, Texas, United States, 78229|