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This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.
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 oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation and Expansion | Experimental | CG-806 will be given orally 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG-806 | Drug | CG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events of CG-806 | To determine the safety and tolerability of CG-806. | Cycle 1 (28 days) |
| Establish a CG-806 dose that maintains a biologically active plasma concentration | 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. | Cycle 1 (28 days) |
| Establish recommended dose for future development of CG-806 | To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL. | Up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables including maximum plasma concentration (Cmax) | Pharmacokinetic variables including maximum plasma concentration (Cmax) | Cycle 1 (28 days) |
| Pharmacokinetic variables including minimum plasma concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Bejar, MD, PhD | Aptose Biosciences Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Pacific Cancer Care |
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|
Pharmacokinetic variables including minimum plasma concentration (Cmin)
| Cycle 1 (28 days) |
| Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC | Pharmacokinetic variables including Area Under the Curve (AUC) | Cycle 1 (28 days) |
| Pharmacokinetic variables including volume of distribution | Pharmacokinetic variables including volume of distribution | Cycle 1 (28 days) |
| Pharmacokinetic variables including clearance | Pharmacokinetic variables including clearance | Cycle 1 (28 days) |
| Pharmacokinetic variables including serum half-life | Pharmacokinetic variables including serum half-life | Cycle 1 (28 days) |
| To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations | To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations | Average 2 Cycles (8 weeks) |
| Pharmacodynamic biomarkers of drug effect including BTK activity | Pharmacodynamic biomarkers of drug effect including BTK activity | Average 2 cycles (8 weeks) |
| Pharmacodynamic biomarkers of drug effect including selected mRNA levels | Pharmacodynamic biomarkers of drug effect including selected mRNA levels | Average 2 cycles (8 weeks) |
| To assess the relative BA of formulation G1 against formulation G2 | To assess the relative bioavailability of original formulation (G1) against new generation formulation (G2). | Cycle 1 (28 days) |
| To assess the relative BA of formulation G1 against formulation G3 | To assess the relative bioavailability of original formulation (G1) against new generation formulation (G3). | Cycle 1 Lead-Up (3 days) |
| Monterey |
| California |
| 93940 |
| United States |
| Torrance Memorial Physician Network | Redondo Beach | California | 90277 | United States |
| UCSD Moores Cancer Center | San Diego | California | 92093 | United States |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | United States |
| Ridley-Tree Cancer Center | Santa Barbara | California | 93105 | United States |
| St. Joseph Heritage Heathcare | Santa Rosa | California | 95403 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | United States |
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| SCL Health, St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Manhattan Hematology Oncology | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Prisma Health - ITOR | Greenville | South Carolina | 29605 | United States |
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | 29732 | United States |
| Texas Oncology - Austin-Midtown | Austin | Texas | 78705 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | United States |
| University of Texas, M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio, Mays Cancer Center | San Antonio | Texas | 78229 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Northwest Cancer Specialists, P.C. - Compass Oncology | Vancouver | Washington | 98684 | United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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