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

NCT02034227 | Terminated Phase 1

• 1 other identifier: CL-2000-II-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia

Keywords

leukemia

Outcome Measures

Primary Outcomes (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.

  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)

• safety profile

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

• 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)

  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

  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),

  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.

Study Arms (2)

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.

Drug: SG2000

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.

Drug: SG2000

Interventions

SG2000 DRUG

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

Also known as: DNA minor groove binding agent

SG2000 - 15 µg/m2/day; SG2000 - 30 µg/m2/day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spirogen: lead

Study Sites (2)

Duke University

Durham, North Carolina, 27705, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 13, 2014
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 23, 2015

Record last verified: 2015-11

Locations

US (2)