Solid Tumors Clinical Trial
— ME-344-001Official title:
Phase 1 Open Label Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 as a Single Agent in Patients With Refractory Solid Tumors
The purpose of this study is to determine the tolerability of ME-344, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Provision of informed consent - Male or female = 18 years of age - Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives. - ECOG Performance status 0-1 (Appendix A) - A minimum life expectancy of 12 weeks - Adequate bone marrow, hepatic and renal function as evidenced by: - Absolute neutrophil count (ANC) > 1.5 x 109/L - Platelet count > 100 x 109/L - Hemoglobin > 9.0 g/dL - Serum bilirubin < 1.5 x ULN - AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases - Serum creatinine < 1.5 x ULN - Adequate cardiac function as evidenced by: - CK-MB within normal levels at baseline - Troponin T within normal levels at baseline - The average QTc from triplicate screening ECGs (every 5 minutes over a total of 15 minutes) must be < 470 msec to be eligible for the study. (If a patient has an average QTc interval >470 msec at screening, the screening ECG may be repeated twice (at least 24 hours apart). - LV Ejection Fraction > lower limit of institutional normal level - All potentially fertile patients will agree to use an effective form of contraception during the study and for 30 days following the last dose of ME-344 (an effective form of contraception is defined as an oral contraceptive or a double barrier method). - At least 4 weeks must have elapsed prior to Day 1 Cycle 1 since prior chemotherapy (6 weeks for nitrosourea or mitomycin C), investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to = NCI-CTCAE Grade 1. - At least 21 days must have elapsed prior to Day 1 Cycle 1, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 Gy. Exclusion Criteria: - Patients who are pregnant or breastfeeding - Tumor involvement of the Central Nervous System (CNS): - Patients with treated and stable CNS metastases may be eligible to participate after discussion and approval from the Medical Monitor - Uncontrolled infection or systemic disease. - Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months. - Any major surgery, radiotherapy, or immunotherapy within the last 21 days. Limited palliative radiation, defined as encompassing <25% of total bone marrow volume and not exceeding a total dose of 30 Gy, within the last 14 days. - Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential or delayed toxicity within the last 2 weeks. - No concurrent systemic chemotherapy or biologic therapy is allowed. - Known hypersensitivity to any components of ME-344 study drug product. - Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both). - History of solid organ transplantation. - Psychiatric disorder or social or geographic situation that would preclude study participation. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | Florida Cancer Specialists | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
MEI Pharma, Inc. | SCRI Development Innovations, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose limiting toxicity | Patients will be administered ME-344 IV infusions weekly for 3 weeks during the first 28 days cycle for dose limiting toxicity. Patients will be assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis, ECG, echocardiogram and pharmacokinetic sampling. | One Cycle of 28 days | Yes |
Secondary | Response Rate | Radiologic assessments will be performed at baseline and a minimum of every 12 weeks. Patients may continue weekly dosing if there is clinical beneficial determined by the Investigator. | baseline and a minimum of every 12 weeks | No |
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