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Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor:Tolerability and Pharmacokinetics


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Advanced Solid Tumor

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Trial Information

Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor:Tolerability and Pharmacokinetics


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Jinwan Wang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

LP-101

NCT ID:

NCT01832298

Start Date:

December 2012

Completion Date:

June 2014

Related Keywords:

  • Advanced Solid Tumor
  • Tolerability
  • Pharmacokinetics
  • Neoplasms

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