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

NCT01401868 | Completed Phase 1 DMC

• 1 other identifier: ME-143-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumors

Keywords

solid tumor; recurrent; advanced; metastatic

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

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

  within the first 28 day cycle

Secondary Outcomes (1)

• Response rate

  baseline and a minimum of every 12 weeks

Study Arms (1)

single arm

EXPERIMENTAL

dose escalation

Drug: ME-143

Interventions

ME-143 DRUG

experimental drug, dose escalation with 4 dose cohorts of 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. If either the 10 mg/kg or 20 mg/kg dose levels are not tolerable, a 7.5 mg/kg or a 15 mg/kg dose level will be evaluated. 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 per 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

single arm

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
• 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.

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.
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Related Links

• Sponsor's web site
• manuscript

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis

Interventions

ME-143; 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 25, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (2)