Status:
COMPLETED
Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid Tumors
Lead Sponsor:
MEI Pharma, Inc.
Collaborating Sponsors:
SCRI Development Innovations, LLC
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
Detailed Description
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, dose limiting toxicities, and the safety profile in patients with refractory solid tumors. In add...
Eligibility Criteria
Inclusion
- 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
- 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) \< or = 2.5 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases
- Serum creatinine \< or = 1.5 x ULN
- Follicle-Stimulating Hormone (FSH) within normal baseline levels
- Male patients should have a detectable level of testosterone
- Female patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin β-hCG\]) within 1 week of starting the study.
- All potentially fertile patients will agree to use an effective form of contraception during the study and for 90 days following the last dose of ME-143 (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 carmustine 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 (limited palliative radiation is allowed \> 2 weeks), immunotherapy or following major surgery and any surgical incision should be completely healed
Exclusion
- 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.
- Patients with QTc of \> 470 msec on screening ECG. (If a patient has QTc interval \>470 msec on screening ECG, the screening ECG may be repeated twice (at least 24 hours apart). The average QTc from the 3 screening ECGs must be \<470 msec in order for the patient to be eligible for the study.
- Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed \> 2 weeks).
- 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-143 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01401868
Start Date
September 1 2011
End Date
January 1 2013
Last Update
June 24 2013
Active Locations (2)
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1
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
2
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203