Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan Monotherapy and Combination in Patients With Advanced Solid Tumors
NCT02870036 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 243
Last updated 2017-07-14
Summary
This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and Leucovorin Calcium,thalidomide in patients with advanced solid tumor or advanced/metastatic colorectal cancer.
Conditions
- Advanced Solid Tumor
- Advanced/Metastatic Colorectal Cancer
Interventions
- DRUG
-
Simmitecan
- DRUG
-
5-fluorouracil and Leucovorin Calcium
- DRUG
-
Thalidomide
Sponsors & Collaborators
-
Haihe Biopharma Co., Ltd.
lead INDUSTRY
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
- 2016-10-31
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- China
Study Locations
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