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

NCT ID: NCT02034227

Last Updated: 2015-11-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SG2000 - 15 µg/m2/day

Cohort 1 - will commence at 15 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.

Group Type: EXPERIMENTAL

SG2000

Intervention Type: DRUG

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

SG2000 - 30 µg/m2/day

Cohort 2 - will commence at 30 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.

Group Type: EXPERIMENTAL

SG2000

Intervention Type: DRUG

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

Interventions

SG2000

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

Intervention Type: DRUG

Other Intervention Names

DNA minor groove binding agent

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spirogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

CL-2000-II-01

Identifier Type: -

Identifier Source: org_study_id