Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034227
Recruitment Status : Terminated
First Posted : January 13, 2014
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Spirogen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Chronic Lymphocytic Leukemia Drug: SG2000 Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SG2000 - 15 µg/m2/day
Cohort 1 - will commence at 15 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
 Drug: SG2000
intravenous doses given on Days 1, 2, and 3 of each 21-day cycle (1 to 6 cycles).
Other Name: DNA minor groove binding agent
Experimental: SG2000 - 30 µg/m2/day
Cohort 2 - will commence at 30 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
 Drug: SG2000
intravenous doses given on Days 1, 2, and 3 of each 21-day cycle (1 to 6 cycles).
Other Name: DNA minor groove binding agent


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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). ]
    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 :
  1. safety profile [ Time Frame: day -1 to day- 21 for six 21-day cycles . ]

    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.


  2. 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. ]
    pharmacokinetic (PK) parameter, noncompartmental analysis will be performed to estimate the plasma pharmacokinetic (PK) parameters of SG2000. Area under the concentration-time curve (AUC).

  3. 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. ]
    pharmacokinetic (PK) parameter -Cmax is the observed maximum plasma or serum concentration after administration

  4. 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. ]
    pharmacokinetic (PK) parameter - time to reach Cmax.

  5. 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. ]
    pharmacokinetic parameter - terminal half life

  6. hematology and serum chemistry [ Time Frame: baseline, days 1,2,3,4,8,15, and 21 for six 21-day cycles. ]
    predictors of Vascular Leak Syndrome (VLS)

  7. Physical examination [ Time Frame: baseline, day-1 to day 21 for six 21-day cycles. ]
    predictors of Vascular Leak Syndrome (VLS)

  8. Vital signs [ Time Frame: baseline, day-1 to day-21 for six 21-day cycles. ]
    predictors of Vascular Leak Syndrome (VLS)

  9. bone marrow aspirate [ Time Frame: day-1 (predose), and day 8 of Cycles 1 and 3 , and day 1 of Cycles 2 and 4 ]
  10. pulse oximetry [ Time Frame: baseline, day-1 to day-21 for six 21-day cycles. ]
    monitoring for Vascular Leak Syndrome (VLS)

  11. electrocardiogram [ Time Frame: days 1, 8, 15, 21, and at Day 22 after the last cycle or early termination. ]
  12. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02034227


Locations
Layout table for location information
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Spirogen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Spirogen
ClinicalTrials.gov Identifier: NCT02034227    
Other Study ID Numbers: CL-2000-II-01
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015
Keywords provided by Spirogen:
leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell