Phase I Study of CM082 Tablets in the Treatment of Advanced Malignant Solid Tumors: Safety, Tolerance and Pharmacokinetics

AnewPharma1 site in 1 country19 target enrollmentFebruary 26, 2019

ConditionsAdvanced Malignant Solid Tumors

InterventionsCM082

Overview

Phase: Phase 1
Intervention: CM082
Conditions: Advanced Malignant Solid Tumors
Sponsor: AnewPharma
Enrollment: 19
Locations: 1
Primary Endpoint: Maximum tolerable dose (MTD) or dose to absorb saturation
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Dosing of CM082 tablets in Chinese Patients With Advanced Malignant Solid Tumors

Detailed Description

This is a single-center、open-label and non-controlled Phase 1 study which will be conducted in two parts: part A is the dose-escalation phase; part B is dose-expansion phase. The dose-escalation phase is guided by pharmacokinetics (PK) and safety, according to the standard 3+3 dose-escalation schema. CM082 tablets are taken orally with a starting dose of 200 mg and a subsequent dose of 400, 600 and 800 mg. The way of administration is as follows: QD or BID. The primary objective of this study is to determine the maximum tolerable dose (MTD)、characteristics of dose-limited toxicity (DLT) and pharmacokinetics (PK). Secondary objectives include safety、tolerability and preliminary efficacy

Registry

clinicaltrials.gov

Start Date

February 26, 2019

End Date

June 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

AnewPharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age:≥18 years.
•BMI generally ranges from 18-28 (BMI=Weight (Kg)/Height (m)2)
•Patients with advanced malignant solid tumors confirmed by histological or cytological examination.
•According to Recist1.1 criteria, patients have measurable or assessable tumors, and patients with advanced malignant solid tumors who have failed to respond to previous standard treatment regimens, are unable to tolerate previous treatment regimens or lack effective treatment regimens.
•Organ function level must meet the following requirements (7 days before treatment):
•Bone marrow: absolute neutrophil count (ANC)≥1.5\^109/L, platelet (PLT)≥100\^109/L, hemoglobin (HB)≥9g/dL (no blood transfusion or component blood received within 14 days before detection).
•Liver: Serum bilirubin (TBIL) ≤1.5 \* upper limit of normal (ULN) , aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 \* ULN (If the patient's liver metastases, AST and ALT are allowed to be ≤ 5 \* ULN) ).
•Serum creatinine≤1.5 \* ULN and endogenous creatinine clearance rate≥50mL/min. According to Cockcroft-Gault formula, Please refer to attachment 7 for details.
•International normalized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 \* ULN (This provision applies only to patients who do not receive anticoagulant treatment; for patients receiving anticoagulant treatment, anticoagulants should be used within the treatment requirements).
•Urine protein (UP)≤1+. If UP\>1+, 24-hour UP should be collected for determination, and the total amount of UP should be ≤1g.

Exclusion Criteria

•Within 4 weeks before the first use of the study drug, the patient received anti- tumor drug therapy such as chemotherapy, targeted therapy, radiotherapy, biological therapy or endocrine therapy, except for the following: Nitrous urea or mitomycin C were used within 6 weeks before the first use of the study drug; Oral fluorouracil and small molecular targeted drugs were used within 2 weeks before the first use of the study drug or within 5 half-lives (whichever is the longer); Chinese medicine with anti-cancer indications was used within 1 week before the first use of the study drug.
•Surgical treatment (except biopsy) was performed within 4 weeks before the first use of study drug.
•Patients who have participated in or are participating in any other drug/therapy clinical trial (including but not limited to the anti-tumor clinical trial) within 4 weeks before treatment, counting from the time of last administration of the last clinical trial.
•Patients who received hematopoietic stimulating factors (e.g., granulocyte colony stimulating factor (G-CSF), erythropoietin, etc.) within one week before treatment.
•Pleural or ascites with clinical symptoms and requiring symptomatic treatment.
•Patients with active pulmonary disease, interstitial pneumonia or pulmonary fibrosis.
•Having any uncontrollable clinical problems or associated risk factors, including but not limited to:
•Poorly controlled hypertension (blood pressure persistently greater than 150/90 mmHg).
•Left ventricular ejection fraction (LVEF)≤50%.
•The QT interval of heart rate correction (QTc) \> 450 msec (males) or 460 msec (females) ( Bazett's correction (QTcB)=QT/(RR\^0.5)).