An Open-Label Phase I/II Clinical Study of PT-112 in Combination With Docetaxel in Subjects With Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects With Non-Small Cell Lung Cancer (NSCLC) in a Phase II Dose Confirmation Study

NCT02884479 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-04-25

No results posted yet for this study

Summary

The purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell Lung Cancer.

Conditions

Interventions

DRUG

PT-112

Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

DRUG

Docetaxel

Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY
  • National Cheng-Kung University Hospital

    collaborator OTHER
  • SciClone Pharmaceuticals International (Cayman) Development Limited

    lead INDUSTRY

Principal Investigators

  • Wu-Chou Su · National Cheng-Kung University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • Taiwan

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 NCT02884479 on ClinicalTrials.gov