Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors

NCT01544322 | Completed Phase 1 DMC

• 1 other identifier: ME-344-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumors

Keywords

solid tumors; recurrent; advanced; metastatic; refractory

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Response Rate

  baseline and a minimum of every 12 weeks

Interventions

ME-344 DRUG

experimental drug, dose escalation with 5 planned dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8, and 15. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal. Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2 days each week. Cycle 1 at the highest dose level is 3 weekly IV infusions on days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.

Also known as: open label, single agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEI Pharma, Inc.: lead
• SCRI Development Innovations, LLC: collaborator

Study Sites (3)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 73104, United States

Location

Related Links

• Sponsor's web site

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis

Interventions

ME-344; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Study Officials

• Robert D Mass, MD

  MEI Pharma, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 5, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 18, 2015

Record last verified: 2014-04

Locations

US (3)