A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

March 23, 2016 updated by: Nanjing Yoko Biomedical Co., Ltd.

A Phase I Study to Determine the Safety and Pharmacokinetic Study of Tafetinib in Patients With Advanced Solid Tumors

Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR).

This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with histologically confirmed advanced solid malignancies.
  • ECOG score 0-1.
  • 18-65 years old.
  • Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks.
  • Function of organs must meet the following requirements:
  • Neutrophil count ≥1500/ul;
  • AST and ALT≤1.5 times the upper limit of normal (ULN);
  • Total serum bilirubin≤1.5 times ULN;
  • Hemoglobin≥90g/L;
  • Platelet≥100000/ul;
  • The creatinine in the normal range or creatinine clearance rate ≥60ml/min;
  • Left ventricular ejection fraction (LVEF) ≥50%;
  • Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study.
  • Written informed consent is obtained.

Exclusion Criteria:

  • included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tafetinib
tafetinib administered daily for 2 weeks, followed by a 1-week off period
Drug: tafetinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity
Time Frame: 3 weeks
Dose-limiting toxicity was defined as any one of the following (NCI-CTCAE Version 4.0): (a) hypertension: uncontrollable grade 3 hypertensive or grade 4. (b) reduced LVEF: 2 degrees or above. (c) neutropenia : 3 degrees or above. (d) thrombopenia: 3 degrees or above. (e) Other Non-hematologic toxicity (not including alopecia, nausea or vomiting): 3 degrees or above.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Yoko Biomedical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • NanjingYoko

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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