A Phase I Study to Assess the Safety and Activity of Combined MG005 and Sorafenib (NEXAVAR®) Treatment in Patients With Solid Tumor

Metagone Biotech Inc.1 site in 1 country17 target enrollmentJune 6, 2018

ConditionsSolid Tumor

InterventionsMG005

DrugsMG005

Overview

Phase: Phase 1
Intervention: MG005
Conditions: Solid Tumor
Sponsor: Metagone Biotech Inc.
Enrollment: 17
Locations: 1
Primary Endpoint: Maximum Tolerated Dose(MTD)and Dose Limiting(DLT) -phase I
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The proposed initial trial is a Phase I, open label study to evaluate the safety and explore efficacy of MG005 in combination with sorafenib in patients with solid tumor. The eligible patients will receive 200 mg of sorafenib with 3 pre-defined dose levels of GW5074, escalated from 750 mg to 1500 mg (daily dose), to determine the Maximum Tolerated Dose (MTD) and dose limiting toxicities (DLT) (if any) at Phase I stage.

Registry

clinicaltrials.gov

Start Date

June 6, 2018

End Date

July 24, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Metagone Biotech Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
•Patients who are ≥ 20 years of age
•Patients with histologically confirmed advanced or metastatic disease that is either refractory to or intolerant of existing standard therapy or for which no effective standard therapy that confers clinical benefit is available (patients may have received prior therapy with sorafenib if not intolerable)
•Patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
•Patient able to provide either an archived tumor sample or with accessible tumor for biopsy and willingness to provide it prior to initiation of study treatment
•At least 4 weeks post any therapeutic modalities (e.g., surgery, radiotherapy, and therapeutic agents) prior to initial dosing except the palliative radiotherapy performed on non-study-related local lesions
•Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2 8.Patient's life expectancy of at least 3 months
•9.Patient has adequate hematopoietic, hepatic function and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
•Hemoglobin ≥ 9.0 g/dL
•Absolute neutrophil count (ANC) ≥ 1,500 cells/μL

Exclusion Criteria

•Patient who has participated in other investigational studies and received any investigational therapy within 4 weeks prior to study dosing
•Patient carries history of primary malignancy other than the entry diagnosis except curatively treated non-melanoma skin cancer, cervical carcinoma in situ, or superficial bladder tumors within 5 years prior to study entry.
•Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of GW5074 and sorafenib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
•Patient with known leptomeningeal or brain metastasis (including those who require glucocorticoids or intrathecal chemotherapy) by radiologic/histological evidence, or only bone metastasis
•Patient with history of significant cardiac disease including superior vena cava, unstable angina, congestive heart failure \> class 2 per New York Heart Association (NYHA) classification, cardiac arrhythmias, cardiac ischemia/infarction, long QT-syndrome (i.e., QTc \> 450 msec for males and \> 470 msec for females), poorly controlled hypertension (systolic blood pressure \> 150 mm-Hg and/or diastolic blood pressure \> 90 mm-Hg on anti-hypersensitive medications), and valvular heart disease
•History of organ or bone marrow transplant
•Patient who has not recovered from side/toxic effects of previous therapy (i.e., NCI-CTCAE grade 1 or less) prior to the first dose of study medications
•Patients who are receiving or with conditions requiring substances that are potent inducers of CYP3A4 activity (e.g., rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone)
•Patients who are receiving or with conditions requiring sensitive substrates of CYP1A2, 1B1, 2C8, 2C19 and 3A4 with narrow therapeutic windows (e.g., theophylline, duloxetine, alosetron, tizanidine, repaglinide, omeprazole, S-mephenytoin, alfentanil, sirolimus, pimozide, and tacrolimus)
•History of stroke or transient ischemic attack within 6 months of study entry

Arms & Interventions

MG005

Cohort 1 :3 × 250 mgMG005+1 × 200 mgSorafenib\[8:00 AM (±2 hours)\] Cohort 2 :6 × 250 mgMG005+1 × 200 mgSorafenib\[8:00 AM (±2 hours)\] Cohort 3 :3 × 250 mgMG005+1 × 200 mgSorafenib; 3 × 250 mgMG005+1 × 200 mgSorafenib\[8:00 AM (±2 hours); 8:00 PM (±2 hours)\]

Intervention: MG005