Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan Monotherapy and Combination in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid TumorAdvanced/Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT02870036
- Lead Sponsor
- Haihe Biopharma Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 243
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacokinetic data investigation of Simmitecan Simmitecan To further determine the pharmacokinetic (PK) characteristics of Simmitecan monotherapy in patients with advanced solid tumors Dose escalation study of Simmitecan combined therapy Simmitecan To determine the maximum tolerated dose (MTD) of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced solid tumor Dose escalation study of Simmitecan combined therapy 5-fluorouracil and Leucovorin Calcium To determine the maximum tolerated dose (MTD) of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced solid tumor Dose extension study of Simmitecan monotherapy Simmitecan To preliminarily evaluate the anti-tumor activity of Simmitecan monotherapy in patients with advanced solid tumors, and to determine the recommended phase II dose (RP2D) Dose extension study of Simmitecan combined Thalidomide Simmitecan To preliminarily evaluate the anti-tumor activity of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced/metastatic colorectal cancer (CRC), and to determine RP2D Dose escalation&extension Simmitecan combined Thalidomide Simmitecan To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with gastrointestinal tumors, and to determine RP2D and MTD Dose extension study of Simmitecan combined therapy Simmitecan To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with specific tumors Dose extension study of Simmitecan combined therapy 5-fluorouracil and Leucovorin Calcium To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with specific tumors Dose extension study of Simmitecan combined Thalidomide Thalidomide To preliminarily evaluate the anti-tumor activity of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced/metastatic colorectal cancer (CRC), and to determine RP2D Dose escalation&extension Simmitecan combined Thalidomide Thalidomide To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with gastrointestinal tumors, and to determine RP2D and MTD
- Primary Outcome Measures
Name Time Method Cmax (maximum plasma concentration) before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan Tmax (time to maximum plasma concentration) before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan AUC (area under the plasma concentration-time curve) before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan T½ before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan CL (systemic clearance) before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan Vz (apparent volume of distribution) before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan Adverse events (AE) AEs will be classified by type, incidence, severity (graded per NCI-CTCAE [version 4.03]), time to onset, seriousness and relationship
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death. Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion.
progression free survival (PFS) Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death. Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion.
CBR (clinical benefit rate) Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death. Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion.
DCR (disease control rate) Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death. Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion.
OS (overall survival) Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death. Tumor will be evaluated according to RECIST-1.1. CT or MRI can be used for tumor imaging at the investigator's discretion.
accumulative excretion rate Accumulative excretion rate within 0-72 h after the first administration of Simmitecan.
Trial Locations
- Locations (9)
Beijing Cancer Hospital
🇨🇳Beijin, Beijing, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
The first hospital of China Medical University
🇨🇳Shenyang, Liaoning, China