K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability
NCT02720666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2017-01-06
Summary
This study is an open and single-center Phase I clinical research on patients with advanced pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to determine the safe and reasonable dosage and dosing regimen.
Conditions
Interventions
- DRUG
-
K-001
In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered as the maximum tolerated dose or the biologically effective dose. After the test, continuous medication shall be given upon request from patients.
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Xingpeng Wang, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- China
Study Locations
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