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
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
- Advanced Solid Tumor
- Non-Small Cell Lung Cancer
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
-
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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