Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas

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: NCT03893682
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Aptose Biosciences Inc.

Brief Summary:
This study is being done to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Non-Hodgkin's Lymphoma Drug: CG-806 Phase 1

Detailed Description:
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the MTD or recommended dose.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Dose Escalation and Expansion
CG-806 will be given in ascending doses in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphomas (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 100 patients enrolled in the expansion cohort at the recommended dose.
Drug: CG-806
CG-806 will be given in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached.




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events of CG-806 [ Time Frame: Cycle 1 (28 days) ]
    To determine the safety and tolerability of CG-806.

  2. Establish a CG-806 dose that maintains a biologically active plasma concentration [ Time Frame: Cycle 1 (28 days) ]
    To determine the dose of CG-806 given orally every 12 hours that maintains a biologically active plasma concentration over a period of 28 days.

  3. Establish recommended dose for future development of CG-806 [ Time Frame: Up to 10 months ]
    To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.


Secondary Outcome Measures :
  1. Pharmacokinetic variables including maximum plasma concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including maximum plasma concentration (Cmax)

  2. Pharmacokinetic variables including minimum plasma concentration (Cmin) [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including minimum plasma concentration (Cmin)

  3. Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including Area Under the Curve (AUC)

  4. Pharmacokinetic variables including volume of distribution [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including volume of distribution

  5. Pharmacokinetic variables including clearance [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including clearance

  6. Pharmacokinetic variables including serum half-life [ Time Frame: Cycle 1 (28 days) ]
    Pharmacokinetic variables including serum half-life

  7. To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations [ Time Frame: Average 2 Cycles (8 weeks) ]
    To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations

  8. Pharmacodynamic biomarkers of drug effect including BTK activity [ Time Frame: Average 2 cycles (8 weeks) ]
    Pharmacodynamic biomarkers of drug effect including BTK activity

  9. Pharmacodynamic biomarkers of drug effect including selected mRNA levels [ Time Frame: Average 2 cycles (8 weeks) ]
    Pharmacodynamic biomarkers of drug effect including selected mRNA levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Life expectancy of at least 2 months
  • ECOG Performance Status ≤ 2
  • Patients must be able to swallow capsules
  • Adequate hematologic parameters, unless cytopenias are disease caused
  • Adequate renal, liver and cardiac function parameters

Exclusion Criteria:

  • Patients with GVHD requiring systemic immunosuppressive therapy
  • Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
  • Clinically significant intravascular coagulation
  • Treatment with other investigational drugs within 14 days prior to first study treatment administration

Information from the National Library of Medicine

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): NCT03893682


Contacts
Layout table for location contacts
Contact: Nicole Harada 8589262730 nharada@aptose.com
Contact: Ernest Kitt 8589262730 ekitt@aptose.com

Locations
Layout table for location information
United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Ruth Canamar    520-626-4332    rcanamar@uacc.arizona.edu   
Principal Investigator: Daruka Mahadevan, MD, PhD         
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: April Johnson    310-794-6500    AprilDJohnson@mednet.ucla.edu   
Principal Investigator: Herbert Eradat, MD         
Pacific Cancer Care Recruiting
Monterey, California, United States, 93940
Contact: Monica Castillo    831-375-4105    MoCastillo@pacificcancercare.com   
Principal Investigator: Laura Stampleman, MD         
UCSD Moores Cancer Center Recruiting
San Diego, California, United States, 92093
Contact: Kimberly Aguilar    858-534-5201    k1aguilar@ucsd.edu   
Principal Investigator: Erin Reid, MD         
Sharp Clinical Oncology Research Not yet recruiting
San Diego, California, United States, 92123
Contact: Stephanie Manoff    858-939-5063    Stephanie.Manoff@sharp.com   
Contact: Alaina Lee    858-939-5062    Alaina.Lee@sharp.com   
Principal Investigator: Kai Zu, MD         
United States, Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Nicole Glynn-Cunningham, MS    410-328-7996    nglynn@umm.edu   
Principal Investigator: Seung Tae Lee, MD, PhD         
Rcca Md, Llc. Recruiting
Bethesda, Maryland, United States, 20817
Contact: Natalie Bongiorno    301-571-2016    nbongiorno@regionalcancercare.org   
Principal Investigator: Victor Priego, MD         
United States, Montana
SCL Health, St. Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
Contact: Heather Duyck    406-238-6996    heather.duyck@sclhealth.org   
Principal Investigator: Patrick Cobb, MD         
United States, New Jersey
Morristown Medical Center Not yet recruiting
Morristown, New Jersey, United States, 07960
Contact: Christine Koranyi, BS, MS, RN    862-881-9131    Christine.Koranyi@atlantichealth.org   
Principal Investigator: Mohamad Cherry, MD, MS         
United States, New York
Manhattan Hematology Oncology Recruiting
New York, New York, United States, 10016
Contact: Phenoia Browne    212-689-6791 ext 228    pbrowne@mhony.com   
Contact: Peter Okpara    212-689-6791 ext 115    pokpara@mhony.com   
Principal Investigator: Alec S. Goldenberg, MD         
United States, South Carolina
Prisma Health - ITOR Not yet recruiting
Greenville, South Carolina, United States, 29605
Contact: Jill Roemmich, RN    864-455-6962    jroemmich@ghs.org   
Principal Investigator: Elizabeth Cull, MD         
Carolina Blood and Cancer Care Associates Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Dhwani Mehta, MS, BCMAS    803-329-7772    dmehta@cbcca.net   
Principal Investigator: Niyati Nathwani, MD         
United States, Texas
Texas Oncology - Austin-Midtown Recruiting
Austin, Texas, United States, 78705
Contact: Francisca Fernandez    512-421-4183      
Principal Investigator: Jason Melear, MD         
Texas Oncology - Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Catinna Mallett    214-818-8325    catinna.mallett@usoncology.com   
Contact: Carol Oriente       carol.oriente@usoncology.com   
Principal Investigator: Moshe Yair Levy, MD         
Texas Oncology - Fort Worth Cancer Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Veronica Reyes    817-413-1763    Veronica.Reyes@usoncology.com   
Principal Investigator: Stephen L. Richey, MD, MPH         
University of Texas, M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Janel C Mitchell, M.Ed.    713-563-4354    jmdennison@mdanderson.org   
Contact: Lore Lagrone    713-563-2952    llagrone@mdanderson.org   
Principal Investigator: Felipe Samaniego, MD         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Shelly Maxfield    903-579-9840    Shelly.Maxfield@USOncology.com   
Principal Investigator: Habte A. Yimer, MD         
Sponsors and Collaborators
Aptose Biosciences Inc.
Investigators
Layout table for investigator information
Study Director: Stephen Howell, MD Aptose Biosciences Inc.

Layout table for additonal information
Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT03893682     History of Changes
Other Study ID Numbers: APTO-CG-806-01
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell