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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720666 on ClinicalTrials.gov