ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors

NCT02100007 | Terminated Phase 1 Results

• 1 other identifier: ME-344-002
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 10

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

Conditions

Solid Tumors

Keywords

solid tumors; relapsed; advanced; metastatic; small cell lung cancer; ovarian cancer; refractory

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events

  The AE Profile will be determined by the number of AEs regardless of severity

  Through study completion- an average of 2 years

• Number of Serious Adverse Events

  The SAE Profile will be determined by the number of SAEs

  Through study completion- an average of 2 years

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax)

  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

• Time to Maximum Plasma Concentration for ME-344 (Tmax)

  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

• Minimum Plasma Concentration (Cmin) of ME-344

  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

• Mean Terminal Half-life (t 1/2)

  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

• Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan

  Response was assessed throughout the trial up to 13 months

Study Arms (1)

ME-344

EXPERIMENTAL

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

Drug: ME-344; Drug: Topotecan

Interventions

ME-344 DRUG

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.

Also known as: open label

ME-344

Topotecan DRUG

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.

Also known as: Hycamtin®

ME-344

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

University of WA Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

The Bays St Mary's Hospital

London, England, W2 1NY, United Kingdom

Location

Sarah Cannon Research Instititute UK

London, England, WIG 6AD, United Kingdom

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis; Small Cell Lung Carcinoma; Ovarian Neoplasms

Interventions

ME-344; Topotecan

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Richard Ghalie, MD, Sr Vice President Clinical Development
• Organization: MEI Pharma Inc

rghalie@meipharma.com

858 369-7116

Study Officials

• Richard Ghalie, MD

  MEI Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: March 24, 2014
• First Posted: March 31, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); GB (2)