Status:
TERMINATED
Phase 1 Study of Terameprocol (EM-1421) in Patients With Leukemia
Lead Sponsor:
Erimos Pharmaceuticals
Conditions:
Leukemias
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is designed to determine the safety, maximum tolerated dose,dose limiting toxicity of Terameprocol(EM-1421)and determine the pharmacokinetics (clearance from the blood)of Terameprocol(EM-14...
Detailed Description
The dose of Terameprocol (EM-1421) will be escalated in successive cohorts of 3 patients. Patients will be entered sequentially on each dose level. If none of the first 3 patients at a dose level expe...
Eligibility Criteria
Inclusion
- Patients with histological confirmed relapsed or refractory leukemias for which no standard therapies are available that are expected to result in durable remissions. Eligible are patients with:
- acute myeloid leukemia (AML) by WHO or FAB classification
- acute lymphocytic leukemia (ALL)
- adult T cell leukemia (ATL)
- chronic myeloid leukemia in blast crisis (CML-BP) having failed Bcr-Abl specific kinase inhibitors (e.g. imatinib and/or dasatinib)
- chronic lymphocytic leukemia (CLL)
- poor-risk myelodysplastic syndrome (MDS) \[by WHO \>10% blasts or IPSS groups: Int-2, high\]
- chronic myelomonocytic leukemia (CMML)
- ECOG performance status of 0-1
- Negative pregnancy test within 7 days of start of study drug NOTE: Men and women of child-producing potential must use effective contraceptive methods during the study (e.g. abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device)
- Written informed consent
- In the absence of rapidly progressing disease, the interval from prior therapies to time of study drug administration should be a minimum of 3 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent chronic toxicities from prior chemotherapy must not be greater than grade 1
- Age greater than or equal to 18 years
- Patients must have the following clinical laboratory values:
- Serum creatinine less than or equal to 2.0 mg/dl or creatinine clearance greater than 50ml/hr
- Total bilirubin less than or equal to 1.5x the upper limit of normal unless considered due to Gilbert's syndrome
- Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) less than or equal to 3x the upper limit of normal unless considered due to organ leukemic involvement
Exclusion
- Patients with any one of the following criteria will not be eligible for study participation:
- Uncontrolled intercurrent illness including, but not limited to,
- uncontrolled infection,
- myocardial infarction within previous 3 months,
- symptomatic congestive heart failure (New York Heart Association Class III, IV),
- symptomatic coronary artery disease
- cardiac arrhythmia not controlled by medication NOTE: Patients with controlled infection on antibiotic or antifungal therapy are eligible
- Psychiatric illness/social situations that would limit compliance with study requirements or unwillingness or inability to comply with procedures required in this protocol
- Patients receiving any other standard or investigational treatment for their leukemia NOTE: Hydroxyurea is allowed prior to study drug start and for the first 7 days of therapy
- Pregnant and nursing patients are excluded. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- Patients with known CNS disease
- History of allergic reactions attributed to compounds of similar chemical or biological composition to Terameprocol (EM-1421) or excipients
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00664677
Start Date
August 1 2007
End Date
June 1 2009
Last Update
February 23 2016
Active Locations (1)
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1
UNC, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599