ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors
NCT ID: NCT02100007
Last Updated: 2017-10-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2014-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ME-344
ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle
ME-344
Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.
Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.
Topotecan
Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Interventions
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ME-344
Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.
Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.
Topotecan
Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with ovarian and small cell lung cancer must have failed initial therapy
* Patients with carcinoma of the cervix must have advanced disease not amenable to curative surgery and/or radiation therapy
* Patients may not have received more than 4 prior regimens of therapy
* Patients may not previously have received irinotecan, topotecan or other topoisomerase I inhibitor
* ECOG Performance status 0-1 (Appendix B)
* 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 or creatinine clearance ≥ 60 mL/min as measured by institutional standards
* At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since "limited palliative radiotherapy", defined as a course of therapy encompassing \<25% total bone marrow volume and not exceeding 30 GY.
Exclusion Criteria
* Patients with uncontrolled infection or systemic disease
* Patients with 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 who have toxicity from last prior therapy that has not recovered to at least Grade 1, with the exception of Grade 2 alopecia
* Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
* Patients with any neuropathy \> Grade 1
* Patients with known hypersensitivity to any components of ME-344 or topotecan study drug product
* Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
* Patients with a history of solid organ transplantation
* Patients with presence of concurrent or active malignant disease (other than disease under study) within the last 12 months with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer.
Patients with any psychiatric disorder or social or geographic situation that would preclude study participation
18 Years
ALL
No
Sponsors
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SCRI Development Innovations, LLC
OTHER
MEI Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Ghalie, MD
Role: STUDY_DIRECTOR
MEI Pharma, Inc.
Locations
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Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
University of WA Seattle Cancer Care Alliance
Seattle, Washington, United States
The Bays St Mary's Hospital
London, England, United Kingdom
Sarah Cannon Research Instititute UK
London, England, United Kingdom
Countries
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Related Links
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Sponsor website
Other Identifiers
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ME-344-002
Identifier Type: -
Identifier Source: org_study_id