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Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1

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ClinicalTrials.gov Identifier: NCT02355535
Recruitment Status : Recruiting
First Posted : February 4, 2015
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Oana Danciu, MD, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE February 4, 2015
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE February 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02355535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
Official Title  ICMJE (STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
Brief Summary This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer cells, in patients with advanced malignancies. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Pancreatic Neuroendocrine Tumor
  • Neuroendocrine Tumors
Intervention  ICMJE Drug: PAC-1
PAC-1 is taken orally on days 1-21 of a 28-day cycle.
Other Name: Procaspase Activating Compound-1
Study Arms  ICMJE 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.
Intervention: Drug: PAC-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female ≥ 18 years of age
  2. Diagnosis of advanced solid tumor or hematologic malignancy (limited to lymphoma) that has failed or become intolerant to standard therapy
  3. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, or lymphoma that fulfills the Deauville PET Criteria
  4. Has an ECOG PS of 0, 1, or 2
  5. Has total bilirubin < 1.5 mg/dL, serum albumin > 3.0 gm/dL, AST and ALT < 1.5 ULN or < 3 x ULN for subjects with known hepatic metastases
  6. Has serum creatinine < 1.5 × ULN
  7. Has hemoglobin ≥ 10 g/dL, ANC ≥ 1.5 × 109/L, and platelet count ≥ 100 × 109/L
  8. Must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after capsule(s) administration
  9. Must be willing and able to comply with study
  10. Has read, understood, and signed the ICF
  11. Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP
  12. Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative
  13. Prior systemic treatments for metastatic disease are permitted but may not be ongoing, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy
  14. Willingness to donate blood for biomarker studies related to the type of therapies used in this trial and the tumor types being treated

Exclusion Criteria:

  1. Had surgery within 4 weeks prior to study treatment except for minor procedures (hepatic biliary stent placement is allowed)
  2. Gliomas are excluded, as well as any history of brain metastases, seizures or underlying brain injury
  3. May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last 3 weeks, or nitrosureas within the last 6 weeks prior to study treatment.
  4. Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
  5. Has a history of an arterial thromboembolic event within the prior six months including CVA, TIA, MI, or unstable angina
  6. Has uncontrolled HIV or hepatitis B or C
  7. Has any clinically significant infection
  8. Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF
  9. Radiation therapy to more than 25% of the bone marrow
  10. Prior allogeneic bone marrow or organ transplantation
  11. > Grade 1 peripheral neuropathy within 14 days before enrollment.
  12. Patient has received other investigational drugs with 14 days before enrollment
  13. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation
  14. Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant (such as acute ischemia, left bundle branch block, ventricular arrhythmias) or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds)
  15. Presence of any non-healing wound, fracture, or ulcer
  16. Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
  17. Has any mental or medical condition that prevents the patient from giving informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oana C. Danciu, M.D. 312-996-1581 ocdanciu@uic.edu
Contact: Meredith Russell, CCRP 312-355-5112 mrussel3@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02355535
Other Study ID Numbers  ICMJE 2015-0057
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oana Danciu, MD, University of Illinois at Chicago
Study Sponsor  ICMJE Vanquish Oncology, Inc.
Collaborators  ICMJE University of Illinois at Chicago
Investigators  ICMJE
Principal Investigator: Oana C Danciu, M.D. University of Illinois at Chicago
PRS Account Vanquish Oncology, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP