Clinical Trials /

Safety, Tolerability Study of SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia

NCT02034227

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety, Tolerability Study of SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia
  • Official Title: An Open-Label, Phase 1/Phase 2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of the DNA Minor Groove Binding Agent SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: CL-2000-II-01
  • NCT ID: NCT02034227

Conditions

  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
SG2000DNA minor groove binding agentSG2000 - 15 µg/m2/day

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SG2000 - 15 µg/m2/dayExperimentalCohort 1 - will commence at 15 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
  • SG2000
SG2000 - 30 µg/m2/dayExperimentalCohort 2 - will commence at 30 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
  • SG2000

Eligibility Criteria

        Inclusion Criteria:

          -  male or female greater than or equal to 18 years of age

          -  have one of the following disease states: Acute Myeloid Leukemia (AML) (age <60 years)
             with relapsed/refractory disease; •Chronic Lymphocytic Leukemia (CLL) with relapsed
             disease following a fludarabine-based regimen or relapsed disease following an
             alkylator-based regimen

          -  are recovered from the acute adverse effects of prior therapies (excluding alopecia
             and Grade ≤2 neuropathy).

          -  have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000
             mg daily).

          -  have adequate hepatic function and renal function

          -  have an estimated life expectancy of >3 months

          -  female subject must have a negative serum pregnancy result within 7 days before the
             start of the study; Both men and women must agree to use a medically acceptable form
             of contraception throughout the treatment period and for 3 months after
             discontinuation of treatment

        Exclusion Criteria:

          -  are eligible for any standard therapy known to be life prolonging or life saving

          -  have diagnosis of AML French-American-British (FAB) classification (FAB) M3 (acute
             promyelocytic leukemia (APL))

          -  are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or
             hormonal treatment for cancer.

          -  have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide
             at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of
             other investigational agents within 4 weeks before study entry.

          -  prior radiation therapy with volume of bone marrow treated over 25%.

          -  use of immunosuppressive therapy, including systemic steroids within 7 days before the
             first dose of SG2000.

          -  hyperleukocytosis (blast counts >30 000/mm3).

          -  history of allogeneic stem cell or solid organ transplantation.

          -  positive serology for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
             or have HIV-AIDS, or active hepatitis B or C.

          -  history of other invasive malignancy within 3 years except for cervical carcinoma in
             situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast
             that has been surgically cured.

          -  have any coexisting medical condition that will substantially increase the risk
             associated with the subject's participation in the study.

          -  have psychiatric disorders or altered mental status precluding understanding of the
             informed consent process and/or completion of necessary studies.

          -  have persistent Grade 2 or greater toxicities from any cause (except alopecia or
             peripheral neuropathy).

          -  are pregnant or breast-feeding.
      
Maximum Eligible Age:60 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of SG2000.
Time Frame:From 1st dose of SG2000 given on days 1, 2 and 3, every 21-days, for six 21-day cycles (approximately 16 weeks).
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:safety profile
Time Frame:day -1 to day- 21 for six 21-day cycles .
Safety Issue:
Description: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.
Measure:area under the concentration-time curve (AUC)
Time Frame: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.
Safety Issue:
Description:pharmacokinetic (PK) parameter, noncompartmental analysis will be performed to estimate the plasma pharmacokinetic (PK) parameters of SG2000. Area under the concentration-time curve (AUC).
Measure:Maximum plasma concentration (Cmax)
Time Frame: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.
Safety Issue:
Description:pharmacokinetic (PK) parameter -Cmax is the observed maximum plasma or serum concentration after administration
Measure:time to reach Cmax
Time Frame: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.
Safety Issue:
Description:pharmacokinetic (PK) parameter - time to reach Cmax.
Measure:terminal half life (T1/2),
Time Frame: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.
Safety Issue:
Description:pharmacokinetic parameter - terminal half life
Measure:hematology and serum chemistry
Time Frame:baseline, days 1,2,3,4,8,15, and 21 for six 21-day cycles.
Safety Issue:
Description:predictors of Vascular Leak Syndrome (VLS)
Measure:Physical examination
Time Frame:baseline, day-1 to day 21 for six 21-day cycles.
Safety Issue:
Description:predictors of Vascular Leak Syndrome (VLS)
Measure:Vital signs
Time Frame:baseline, day-1 to day-21 for six 21-day cycles.
Safety Issue:
Description:predictors of Vascular Leak Syndrome (VLS)
Measure:bone marrow aspirate
Time Frame:day-1 (predose), and day 8 of Cycles 1 and 3 , and day 1 of Cycles 2 and 4
Safety Issue:
Description:
Measure:pulse oximetry
Time Frame:baseline, day-1 to day-21 for six 21-day cycles.
Safety Issue:
Description:monitoring for Vascular Leak Syndrome (VLS)
Measure:electrocardiogram
Time Frame:days 1, 8, 15, 21, and at Day 22 after the last cycle or early termination.
Safety Issue:
Description:
Measure:bone marrow aspirate
Time Frame:day-1 (predose), and day- 8 of each 21-day cycle (cycles 1 and 3) and day -1 of cycles 2 and 4
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Spirogen

Trial Keywords

  • leukemia

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