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Acute Myeloid LeukemiaPhase 1/2NCT02034227

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

A Phase 1/2 study testing SG2000 in people with Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by Spirogen at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
SG2000
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
Apr 2012to Jun 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

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

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.

Being tested
SG2000
Keywords
leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SG2000Drug

    Also called DNA minor groove binding agent

    intravenous doses given on Days 1, 2, and 3 of each 21-day cycle (1 to 6 cycles).

Study groups in NCT02034227
Study groupRoleWhat they receive
SG2000 - 15 µg/m2/dayExperimentalCohort 1 - will commence at 15 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
Receives: Drug: SG2000
SG2000 - 30 µg/m2/dayExperimentalCohort 2 - will commence at 30 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
Receives: Drug: SG2000

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From 1st dose of SG2000 given on days 1, 2 and 3, every 21-days, for six 21-day cycles (approximately 16 weeks).

Secondary outcomes (12)

  1. 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.

    Measured: day -1 to day- 21 for six 21-day cycles .

  2. 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).

    Measured: 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.

  3. Maximum plasma concentration (Cmax)

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

    Measured: 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.

  4. time to reach Cmax

    pharmacokinetic (PK) parameter - time to reach Cmax.

    Measured: 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.

  5. terminal half life (T1/2),

    pharmacokinetic parameter - terminal half life

    Measured: 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.

  6. hematology and serum chemistry

    predictors of Vascular Leak Syndrome (VLS)

    Measured: baseline, days 1,2,3,4,8,15, and 21 for six 21-day cycles.

  7. Physical examination

    predictors of Vascular Leak Syndrome (VLS)

    Measured: baseline, day-1 to day 21 for six 21-day cycles.

  8. Vital signs

    predictors of Vascular Leak Syndrome (VLS)

    Measured: baseline, day-1 to day-21 for six 21-day cycles.

  9. bone marrow aspirate

    Measured: day-1 (predose), and day 8 of Cycles 1 and 3 , and day 1 of Cycles 2 and 4

  10. pulse oximetry

    monitoring for Vascular Leak Syndrome (VLS)

    Measured: baseline, day-1 to day-21 for six 21-day cycles.

  11. electrocardiogram

    Measured: days 1, 8, 15, 21, and at Day 22 after the last cycle or early termination.

  12. bone marrow aspirate

    Measured: day-1 (predose), and day- 8 of each 21-day cycle (cycles 1 and 3) and day -1 of cycles 2 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2014 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02034227
Sponsor's protocol ID
CL-2000-II-01
Status last verified
Nov 2015
First submitted
6 Jan 2014
Last updated
23 Nov 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SG2000 in people with Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by Spirogen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02034227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.

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