A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
NCT ID: NCT03082053
Last Updated: 2018-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2017-01-31
2018-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan
NCT00503477
A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer
NCT00559117
Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors
NCT00958724
Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases
NCT00501605
A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer
NCT01905111
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study I
Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors
varlitinib
IMP
Study II
Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
varlitinib
IMP
capecitabine
Companion Medication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
varlitinib
IMP
capecitabine
Companion Medication
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)
Exclusion Criteria
* Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
* Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ASLAN Pharmaceuticals
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASLAN Selected sites
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASLAN001-010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.