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Safety, Tolerability and Pharmacokinetics of DCBCI0901 in Patients With Advanced Solid Tumor

NCT02151357 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-10-06

No results posted yet for this study

Summary

* Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor
* Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit.
* Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR) defined as the proportion of patients who continuously receive treatment after Cycle 1 with a best overall response of complete response (CR) or partial response (PR).

Conditions

Interventions

DRUG

DCBCI0901

DCBCI0901 7.5mg/m2 iv infusion for day 1 to day 5 and day 15 to day 20

Sponsors & Collaborators

  • Standard Chem. & Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chia-Chi Lin, Ph.D. · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2016-06-24
Completion
2016-10-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT02151357 on ClinicalTrials.gov