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Phase I Open Label Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 as a Single Agent in Patients With Refractory Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

Phase I Open Label Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 as a Single Agent in Patients With Refractory Solid Tumors

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 addition, the study is planned to characterize the pharmacokinetic profile
of ME-143 and describe any clinical anti-tumor activity observed in patients.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity

Outcome Description:

Patients will be administered ME-143 IV infusions weekly and assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis and pharmacokinetic sampling.

Outcome Time Frame:

within the first 28 day cycle

Safety Issue:


Principal Investigator

Robert D Mass, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MEI Pharma, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

January 2013

Related Keywords:

  • Solid Tumors
  • solid tumor
  • recurrent
  • advanced
  • metastatic
  • Neoplasms



Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Tennessee Oncology, PLLC Clarksville, Tennessee  37043