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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

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

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

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

Type of Study:


Study Design:

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-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.

Outcome Time Frame:

One Cycle of 28 days

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:

May 2012

Completion Date:

December 2013

Related Keywords:

  • Solid Tumors
  • solid tumors
  • recurrent
  • advanced
  • metastatic
  • refractory
  • Neoplasms



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