Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
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|ClinicalTrials.gov Identifier: NCT02355535|
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Pancreatic Neuroendocrine Tumor Neuroendocrine Tumors||Drug: PAC-1||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||May 18, 2020|
|Actual Study Completion Date :||May 18, 2020|
Experimental: Open label
Using a dose-escalation design, PAC-1 is administered orally on days 1-21, at the assigned dose, of a 28-day cycle.
PAC-1 is taken orally on days 1-21 of a 28-day cycle.
Other Name: Procaspase Activating Compound-1
- Maximum Tolerated Dose [ Time Frame: Up to 30 days post last dose ]The primary objective of this study component is to determine the maximum tolerated dose (MTD) of PAC-1 in patients with advanced, previously treated malignancy, by evaluation of toxicity and tolerability.
- Adverse Effects [ Time Frame: Up to 30 days post final dose ]Characterize adverse effects (AE) of PAC-1 in patients with advanced malignancy.
- Disease Response based on RECIST Criteria for patients with solid tumors [ Time Frame: Up to 8 weeks following final dose ]Evaluate clinical response of PAC-1 in patients with solid tumors (RECIST v 1.1).
- Disease Response based on Deauville PET Criteria for patients with lymphoma [ Time Frame: Up to 8 weeks following final dose ]Evaluate clinical response of PAC-1 in patients with lymphoma (Deauville PET 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): NCT02355535
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|Johns Hopkins Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21231|
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55101|
|Principal Investigator:||Oana C Danciu, M.D.||University of Illinois at Chicago|