Overview

This trial is active, not recruiting.

Condition advanced solid tumor
Treatment simmitecan hydrochloride for injection
Phase phase 1
Sponsor ShangHai HaiHe Pharmaceutical
Collaborator Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Start date December 2012
End date March 2016
Trial size 39 participants
Trial identifier NCT01832298, LP-101

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 inhibiting topoisomerase I. Also exerted comparable effects on topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency and pharmacologic profiles, compared with the clinically available CPT analogues.

PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of Simmitecan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dissolving in 2ml water for injection, then transfering to 500 mL of 5% dextrose for i.v.90 minutes
simmitecan hydrochloride for injection
Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg

Primary Outcomes

Measure
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
time frame: 2 weeks

Secondary Outcomes

Measure
Pharmacokinetic Assessment
time frame: 1-4 days
Efficacy Assessments
time frame: 0-6 weeks
Pharmacodynamic Assessments
time frame: 0 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor:Tolerability and Pharmacokinetics
Principal investigator Jinwan Wang, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by ShangHai HaiHe Pharmaceutical.