Study Stopped
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Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
A Phase 1B Study of Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
1 other identifier
interventional
13
1 country
2
Brief Summary
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 gastric-cancer
Started May 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedStudy Start
First participant enrolled
May 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2019
CompletedMay 8, 2023
November 1, 2022
3.1 years
June 25, 2015
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
patients with adverse events/all patients\*100%
54 weeks
Secondary Outcomes (2)
Tumor response
54 weeks
Progression-free survival time
54 weeks
Study Arms (1)
donafenib tosilate tablets
EXPERIMENTAL200mg bid
Interventions
Eligibility Criteria
You may qualify if:
- All patients provided written, informed consent.
- Have histological or cytological documentation of gastric adenocarcinoma;
- Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
- Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy of at least 3 months;
- Have adequate bone-marrow, liver, and renal function at the start of the trial.
- Prothrombin time international normalized ratio≤1.5；
You may not qualify if:
- Patients with brain metastases.
- Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
- Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Affiliated Cancer Center of Academy of Military Medical Sciences
Beijing, 100071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bao Rui, Doctor
The affiliated hospital of Nanjing University Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2015
First Posted
July 2, 2015
Study Start
May 16, 2016
Primary Completion
June 13, 2019
Study Completion
June 13, 2019
Last Updated
May 8, 2023
Record last verified: 2022-11