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The purpose of this study is to determine if the experimental drug, SG2000 is safe and tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who are not candidates for other types of standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SG2000 - 15 µg/m2/day | Experimental | Cohort 1 - will commence at 15 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined. |
|
| SG2000 - 30 µg/m2/day | Experimental | Cohort 2 - will commence at 30 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SG2000 | Drug | intravenous doses given on Days 1, 2, and 3 of each 21-day cycle (1 to 6 cycles). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of SG2000. | The Maximum Tolerated Dose (MTD) will be determined based on the assessment of the dose-limiting toxicity (DLT) during the DLT period; period is defined as the time from the first dose intravenous doses of SG2000 for 3 consecutive days every 21 days for 1 to 6 cycles until unacceptable toxicity, consent withdrawal, or another reason to discontinue therapy intervenes. | From 1st dose of SG2000 given on days 1, 2 and 3, every 21-days, for six 21-day cycles (approximately 16 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| safety profile | Any subject who receives at least 1 dose of SG2000 will be evaluated for safety. Subjects will be monitored for adverse events (AEs) and will undergo safety assessments including full physical examination, vital sign assessment, Eastern Cooperative Oncology Group (ECOG) performance status assessment, and laboratory testing. | day -1 to day- 21 for six 21-day cycles . |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States | ||
| Medical University of South Carolina |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| area under the concentration-time curve (AUC) | pharmacokinetic (PK) parameter, noncompartmental analysis will be performed to estimate the plasma pharmacokinetic (PK) parameters of SG2000. Area under the concentration-time curve (AUC). | day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes(end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion. |
| Maximum plasma concentration (Cmax) | pharmacokinetic (PK) parameter -Cmax is the observed maximum plasma or serum concentration after administration | day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion. |
| time to reach Cmax | pharmacokinetic (PK) parameter - time to reach Cmax. | day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion. |
| terminal half life (T1/2), | pharmacokinetic parameter - terminal half life | day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion. |
| hematology and serum chemistry | predictors of Vascular Leak Syndrome (VLS) | baseline, days 1,2,3,4,8,15, and 21 for six 21-day cycles. |
| Physical examination | predictors of Vascular Leak Syndrome (VLS) | baseline, day-1 to day 21 for six 21-day cycles. |
| Vital signs | predictors of Vascular Leak Syndrome (VLS) | baseline, day-1 to day-21 for six 21-day cycles. |
| bone marrow aspirate | day-1 (predose), and day 8 of Cycles 1 and 3 , and day 1 of Cycles 2 and 4 |
| pulse oximetry | monitoring for Vascular Leak Syndrome (VLS) | baseline, day-1 to day-21 for six 21-day cycles. |
| electrocardiogram | days 1, 8, 15, 21, and at Day 22 after the last cycle or early termination. |
| bone marrow aspirate | day-1 (predose), and day- 8 of each 21-day cycle (cycles 1 and 3) and day -1 of cycles 2 and 4 |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| 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 |