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

Information source: MEI Pharma, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumors

Intervention: ME-344 (Drug); Topotecan (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: MEI Pharma, Inc.

Official(s) and/or principal investigator(s):
Wendy J Levin, MD, MS, Study Director, Affiliation: MEI Pharma, Inc.

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

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Combination of dosing ME-344 in combination with topotecan in patients with solid tumors

Secondary outcome: Characterize the pharmacokinetic profile of ME-344 in combination with topotecan

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pinnacle Oncology Hematology, Scottsdale, Arizona 85258, United States

University of Colorado Cancer Center, Aurora, Colorado 80045, United States

Sarah Cannon Research Instititute UK, London, England WIG 6AD, United Kingdom

The Bays St Mary's Hospital, London, England W2 1NY, United Kingdom

Northwestern University, Chicago, Illinois 60611, United States

Oncology Hematology Care, Cincinnati, Ohio 45242, United States

University of Oklahoma, Oklahoma City, Oklahoma 73104, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Tennessee Oncology, PLLC, Nashville, Tennessee 37203, United States

University of WA Seattle Cancer Care Alliance, Seattle, Washington 98109, United States

Additional Information

Sponsor website

Starting date: April 2014
Last updated: July 29, 2015

Page last updated: August 23, 2015

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