Trial record 1 of 8 for:
aptose
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
|
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: NCT04477291 |
|
Recruitment Status :
Recruiting
First Posted : July 20, 2020
Last Update Posted : January 5, 2023
|
Sponsor:
Aptose Biosciences Inc.
Information provided by (Responsible Party):
Aptose Biosciences Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myeloid Leukemia Myelodysplastic Syndromes | Drug: CG-806 | Phase 1 |
This is a multicenter, open-label, Phase 1 a/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 Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation. This is to be followed by a cohort expansion phase.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes |
| Actual Study Start Date : | October 6, 2020 |
| Estimated Primary Completion Date : | November 2023 |
| Estimated Study Completion Date : | June 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial acute myeloid leukemia with mutated CEBPA
Cytogenetically normal acute myeloid leukemia
Core binding factor acute myeloid leukemia
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Dose Escalation and Expansion
Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (escalation cohort), until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. Followed up by up to 50 patients enrolled in the expansion cohort at the recommended dose.
|
Drug: CG-806
CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. |
Primary Outcome Measures :
- Incidence of treatment-emergent adverse events of CG-806 [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Patients will be assessed for adverse events during all cycles of treatment and for dose limiting toxicities in Cycle 1 (28-days). Dose escalation to a higher dose level will be considered if none of the first three patients who complete Cycle 1 (28-days) at a given dose level experience a dose limiting toxicity or if only 1 of 6 patients at a given dose level experience a dose-limiting toxicity.
- Establish a CG-806 dose that maintains a biologically active plasma concentration [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]To determine the dose of CG-806 given orally every 12 hours daily that maintains a biologically active plasma concentration during 28-day cycles.
- Establish a recommended dose for future development of CG-806 [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]To establish the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with AML and other advanced myeloid malignancies.
Secondary Outcome Measures :
- Pharmacokinetics variables including maximum plasma concentration (Cmax). [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Pharmacokinetics variables including maximum plasma concentration at various timepoints.
- Pharmacokinetics variables including minimum plasma concentration (Cmin) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Pharmacokinetics variables including minimum plasma concentration at various timepoints.
- Pharmacokinetics variables including area under the curve (AUC) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Pharmacokinetics variables including plasma concentration at various timepoints.
- Pharmacokinetics variables including volume of distribution [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Pharmacokinetics variables including plasma concentration at various timepoints.
- Pharmacokinetics variables including clearance [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Pharmacokinetics variables including plasma concentration at various timepoints.
- Pharmacokinetics variables including plasma half-life. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Pharmacokinetics variables including plasma concentration at various timepoints.
- To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.
- To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, evaluations [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, and FDG PET-CT imaging evaluations.
- To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Compare G1 to G3 pharmacokinetics variables including maximum plasma concentration (Cmax)
- To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Compare G1 to G3 Pharmacokinetics variables including minimum plasma concentration (Cmin)
- To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1. [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Compare G1 to G3 Pharmacokinetics variables including area under the curve (AUC)
- To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Compare G1 to G3 Pharmacokinetics variables including volume of distribution
- To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Compare G1 to G3 Pharmacokinetics variables including clearance
- Compare G1 to G3 Pharmacokinetics variables including clearance [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]Compare G1 to G3 Pharmacokinetics variables including plasma half-life.
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Age ≥18 years
- Life expectancy of at least 3 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 functions
Key Exclusion Criteria:
- Patients with GVHD requiring systemic immunosuppressive therapy
- Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
- Clinically significant leukostasis
- Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration
- Receipt of cellular immunotherapeutic agents within 4 weeks 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): NCT04477291
Contacts
| Contact: Nawazish Khan, MD, MS | 858-275-6359 | nkhan@aptose.com | |
| Contact: Rafael Bejar, MD, PhD | 858-401-6852 | rbejar@aptose.com |
Locations
| United States, California | |
| City of Hope National Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Rochelle Hernandez 626-218-0247 rochernandez@coh.org | |
| Principal Investigator: Paul Koller, MD | |
| St Joseph Heritage Healthcare | Withdrawn |
| Fullerton, California, United States, 92835 | |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Katherine Narvaez-Camacho 305-243-0863 k.narvaez1@med.miami.edu | |
| Principal Investigator: Namrata Chandhok, MD | |
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Madison Klahn 312-926-4963 madison.klahn@northwestern.edu | |
| Principal Investigator: Jessica Altman, MD | |
| United States, Louisiana | |
| Ochsner Healthcare | Recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| Contact: Elise-Marie Curry elisemarie.curry@ochsner.org | |
| Principal Investigator: Laura Finn, MD | |
| United States, New Jersey | |
| Atlantic Hematological Oncology Center | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Leah Zitelli 973-971-6312 leah.cappadona@atlantichealth.org | |
| Principal Investigator: Mohamad Cherry, MD | |
| United States, New York | |
| Roswell Park Comprehensive Cancer Center | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Emily Li 716-845-4176 Emily.Li@RoswellPark.org | |
| Principal Investigator: Eunice Wang, MD | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kaitlyn Tkachuk 646-888-0992 tkachukk@mskcc.org | |
| Contact: Lily Tushman tushmanl@mskcc.org | |
| Principal Investigator: Aaron Goldberg, MD | |
| United States, Ohio | |
| University Hospital of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Sarah Houser 216-286-7082 | |
| Contact: Susan Ackerman 216-286-4150 susan.ackerman2@uhhospitals.org | |
| Principal Investigator: Benjamin Tomlinson, MD | |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Julio Guerrero 713-745-6771 jaguerrero@mdanderson.org | |
| Principal Investigator: Maro Ohanian, DO | |
Sponsors and Collaborators
Aptose Biosciences Inc.
Investigators
| Study Director: | Rafael Bejar, MD, PhD | Aptose Biosciences Inc. |
| Responsible Party: | Aptose Biosciences Inc. |
| ClinicalTrials.gov Identifier: | NCT04477291 |
| Other Study ID Numbers: |
APTO-CG-806-03 |
| First Posted: | July 20, 2020 Key Record Dates |
| Last Update Posted: | January 5, 2023 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Aptose Biosciences Inc.:
|
Aptose CG-806 FLT3 FLT3-ITD D835Y F691L BTK C481S TP53 NRAS IDH1 BCL2 Gilteritinib Quizartinib Midostaurin |
Crenolanib Venetoclax Ibrutinib Acalabrutinib Zanubrutinib LOXO-305 ARQ 531 AML Acute Myeloid Leukemia MDS Myelodysplastic Syndrome CLL Chronic Lymphocytic Leukemia Resistant Refractory |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Syndrome Disease |
Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |