Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

AnewPharma3 sites in 1 country44 target enrollmentMay 2013

ConditionsAdvanced Cancer

InterventionsCM082 Tablet

DrugsCM082 Tablet

Overview

Phase: Phase 1
Intervention: CM082 Tablet
Conditions: Advanced Cancer
Sponsor: AnewPharma
Enrollment: 44
Locations: 3
Primary Endpoint: Maximum Tolerated Dose
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.

Detailed Description

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

May 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AnewPharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
•Eastern Cooperative Group (ECOG) Performance Status score of 0 or
•Life expectancy of at least 12 weeks.
•No immuno deficiency.
•Adequate organ system function, defined as follows:
•Absolute neutrophil count (ANC) ≥1.5 x 10\*\*9/L
•Platelets ≥100 x 10\*\*9/L
•Hemoglobin ≥10 g/dL
•Total bilirubin ≤1.5 times the upper limit of normal (ULN)
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.

Exclusion Criteria

•Not recovered from prior anti-cancer therapy or surgery.
•Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.
•Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.
•Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
•Females who are pregnant or breastfeeding.
•Those in reproductive ages who refuse to use contraception.
•Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.
•Patients with known central nervous system (CNS) metastases.
•Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).
•Patients with known GI disorders such as vomiting, diarrhea.