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

MEI Pharma

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Solid Tumors

Treatments

Drug: ME-344

Drug: Topotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02100007

ME-344-002

Details and patient eligibility

About

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

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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