Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

NCT ID: NCT01832298

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-08-31

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 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.

Conditions

Advanced Solid Tumor

Keywords

Tolerability; Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simmitecan Hydrochloride for Injection

Dissolving in 2ml water for injection, then transfering to 500 mL of 5% dextrose for i.v.90 minutes

Group Type: EXPERIMENTAL

Simmitecan Hydrochloride for Injection

Intervention Type: DRUG

Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg

Interventions

Simmitecan Hydrochloride for Injection

Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

OTHER

Sponsor Role: collaborator

Haihe Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinwan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Aiping Zhou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Yong Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Qingyuan Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Tumor Hospital Affiliated to Harbin Medical University

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The tumor hospital affiliated to Harbin medical university

Harbin, Heilongjiang, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

LP-101

Identifier Type: -

Identifier Source: org_study_id