Status:
COMPLETED
Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor
Lead Sponsor:
Haihe Biopharma Co., Ltd.
Collaborating Sponsors:
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both in vitro and in vivo by in...
Eligibility Criteria
Inclusion
- Relapsed or refractory to standard therapy or no standard therapy available.
- At least one measurable lesion.
- Age = 18\~65 years.
- ECOG=0-1.
- Life expectancy ≥ 12 weeks.
- More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors.
- Adequate organ function:
- Haemoglobin ≥ 100 g/L, Absolute neutrophil count \[ANC\] ≥ 2×109/L,Platelets ≥ 100 × 109/L), Serum bilirubin ≤ 1.0×ULN, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 1.5×ULN (If liver metastases, serum transaminase ≤ 2.5×ULN), Creatinine clearance ≥ 50 mL/min , LVEF ≤ 50%, QT interval (corrected by Fridericia): male \< 450 ms, female \< 470 ms
- Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion
- Less than 4 weeks from the last clinical trial.
- Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening.
- Patients had ever severe diarrhea with prior therapy of camptothecin drugs.
- Concurrent severe or uncontrolled medical disease (serious infection, serious diabetes)
- Significant cardiovascular disease or condition including ≥ class II cardiac function (NYHA)
- Acute and chronic viral hepatitis. (If HBsAg +, HBV-DNA quantification ≤ LLN.)
- Pregnant, lactation period or men/women ready to birth.
- Psychiatric disorder or altered mental status.
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01832298
Start Date
December 1 2012
End Date
August 1 2016
Last Update
December 20 2016
Active Locations (3)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
The tumor hospital affiliated to Harbin medical university
Harbin, Heilongjiang, China, 150000
3
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000