Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
|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: NCT02355535|
Recruitment Status : Recruiting
First Posted : February 4, 2015
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lymphoma Gastrointestinal Cancers Genitourinary Cancers Gynecologic Cancers Head and Neck Cancers Melanoma Thoracic Cancers Solid Tumors Lymphomas||Drug: PAC-1||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 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|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
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
|Contact: Oana C. Danciu, M.D.||firstname.lastname@example.org|
|Contact: Meredith Russell, CCRPemail@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Oana Danciu, MD 312-996-1581 firstname.lastname@example.org|
|Contact: Alisha Williams, RN (312) 413-2746 email@example.com|
|United States, Maryland|
|Johns Hopkins Kimmel Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Matthias Holdhoff, MD, PhD 410-955-8804 firstname.lastname@example.org|
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55101|
|Contact: Richard Peterson, MD 651-254-3572 Richard.A.Peterson@HealthPartners.Com|
|Principal Investigator: Richard Peterson, MD|
|Sub-Investigator: Daniel Anderson, MD|
|Sub-Investigator: Kurt Demel, MD|
|Sub-Investigator: Randolph Hurley, MD|
|Sub-Investigator: Balkrishna Jahagirdar, MD|
|Sub-Investigator: Pryia Kumar, MD|
|Sub-Investigator: Steven McCormack, MD|
|Sub-Investigator: Gary Shapiro, MD|
|Sub-Investigator: Peter Hurley, MD|
|Sub-Investigator: Stephanie Kroon, PA-C|
|Sub-Investigator: Angela Martizna, RN|
|Sub-Investigator: Joanna Hill|
|Principal Investigator:||Oana C Danciu, M.D.||University of Illinois at Chicago|