Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

NCT01832298 | Completed Phase 1

• 1 other identifier: LP-101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

  To evaluate the DLT and MTD in patients with advanced solid tumor

  2 weeks

Secondary Outcomes (3)

• Pharmacokinetic Assessment

  1-4 days

• Efficacy Assessments

  0-6 weeks

• Pharmacodynamic Assessments

  0 days

Study Arms (1)

Simmitecan Hydrochloride for Injection

EXPERIMENTAL

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

Drug: Simmitecan Hydrochloride for Injection

Interventions

Simmitecan Hydrochloride for Injection DRUG

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

Simmitecan Hydrochloride for Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haihe Biopharma Co., Ltd.: lead
• Shanghai Institute of Materia Medica, Chinese Academy of Sciences: collaborator

Study Sites (3)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The tumor hospital affiliated to Harbin medical university

Harbin, Heilongjiang, 150000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jinwan Wang, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Aiping Zhou, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Yong Xu, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Qingyuan Zhang, M.D.

  The Tumor Hospital Affiliated to Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 16, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-10

Locations

CN (3)