Solid Tumors Clinical Trial
Official title:
Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors: A Phase Ia Study, Open-label, Dose-escalation Study
Verified date | April 2017 |
Source | Betta Pharmaceuticals Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of BPI-9016M with single doses and multiple doses.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed, locally advanced, or metastatic solid tumor that progressed, or failed to respond to, at least one prior systemic therapy - Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1) - Life expectancy =3 months - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Adequate bone marrow, hepatic, and renal function - Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment - Signed Informed Consent Form Exclusion Criteria: - Prior treatment with agents of HGF/c-Met inhibitors or HGF/c-Met antibody(Including Crizotinib,Cabozantinib,Volitinib etc.) - Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 4 weeks prior to initiation of study treatment - History of organ transplant; had surgery or severe injury within 4 weeks - Adverse events from prior anti-cancer therapy that have not resolved to Grade = 2, except for alopecia - Any evidence of severe or uncontrolled systemic diseases, including CTCAE 3 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease - Pregnant (positive pregnancy test) or lactating women - Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease - Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance - Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) - Inability to comply with study and follow-up procedures - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications |
Country | Name | City | State |
---|---|---|---|
China | Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Peking Union College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Betta Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Progression-free survival | 18-24 months | ||
Primary | Participants with Adverse Events | The safety and tolerability variables include adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology(Maximum Tolerated Dose) , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose). | 24 months | |
Secondary | Cmax | Day 1-3 for single dose, and day 1-21 for steady state | 1 month | |
Secondary | Half-life time | Day 1-3 for single dose, and day 1-21 for steady state | 1 month | |
Secondary | Tmax | Time to Cmax | 1 month |
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