Clinical trial NCT02100007: ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors
Official title: A Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination With Topotecan (Hycamtin®) in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Keywords: solid tumors
relapsed
advanced
metastatic
small cell lung cancer
ovarian cancer
refractory
Lead sponsor: MEI Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2014-03-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)
* 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 tumor involvement of the Central Nervous System (CNS). SCLC patients with previously treated CNS lesions must have stable CNS disease for at least 4 weeks
* 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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Through study completion- an average of 2 years
measure: Number of Serious Adverse Events
timeFrame: Through study completion- an average of 2 years
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
measure: Time to Maximum Plasma Concentration for ME-344 (Tmax)
timeFrame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
measure: Minimum Plasma Concentration (Cmin) of ME-344
timeFrame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
measure: Mean Terminal Half-life (t 1/2)
timeFrame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
measure: Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan
timeFrame: Response was assessed throughout the trial up to 13 months
measure: Estimate the Overall Survival (OS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pinnacle Oncology Hematology
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Seattle
country: United States
facility: University of WA Seattle Cancer Care Alliance
state: Washington
city: London
country: United Kingdom
facility: The Bays St Mary's Hospital
state: England
city: London
country: United Kingdom
facility: Sarah Cannon Research Instititute UK
state: England
Study officials:
affiliation: MEI Pharma, Inc.
name: Richard Ghalie, MD
role: STUDY_DIRECTOR
References: