Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid Tumors

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEI Pharma, Inc.
• Collaborator: SCRI Development Innovations, LLC

Criteria

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

• 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 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.

• 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.