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Phase I Study of Safety and Pharmacokinetics of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors

Phase 1
18 Years
70 Years
Open (Enrolling)

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Trial Information

Phase I Study of Safety and Pharmacokinetics of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors

This will be an open-label, phase I study. This study will evaluate the safety and
pharmacokinetics of HMPL-013 after a single administration followed by a 28-Day continuous
course of therapy; evaluate the safety and preliminary efficacy in an open-label
administration of at the MTD. All subjects of this study will be permitted to continue
therapy with only safety monitoring and bimonthly assessments for progression, if the
product is well tolerated and the subject has stable disease or better.

Inclusion Criteria:

- ≥ 18 and ≤ 70 years of age

- Histological or cytological confirmed solid malignant tumor

- ECOG performance status of 0-1

- Standard regimen failed or no standard regimen available

- Life expectancy of more than 12 weeks

- LVEF ≥ 50%

- Duration from the last therapy is more than 4 weeks for operation or radiotherapy;
more than 4 weeks for prior systemic treatment

- Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 109/L,
neutrophil > 1.5 × 109/L, hemoglobin > 90g/dl ,serum creatinine within upper limit of
normal(ULN), total bilirubin and serum transaminase within upper limit of
normal(ULN), and PT, APTT, TT, Fbg normal

- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

- signed and dated informed consent.Willingness and ability to comply with scheduled
visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria:

- Pregnant or lactating women

- Any factors that influence the usage of oral administration

- Evidence of uncontrolled CNS metastasis

- Intercurrence with one of the following: non-controlled hypertension, coronary artery
disease, arrhythmia and heart failure

- Abuse of alcohol or drugs

- Less than 4 weeks from the last clinical trial

- Previous treatment with VEGF/VEGFR inhibition

- Disability of serious uncontrolled intercurrence infection

- Proteinuria ≥ 2+

- Uncontrolled hemorrhage in GI

- Within 12 months before the first treatment occurs artery/venous thromboembolic
events, such as cerebral vascular accident (including transient ischemic attack) etc.

- Within 6 months before the first treatment occurs acute myocardial infarction, acute
coronary syndrome or CABG

- Bone fracture or wounds that was not cured for a long time

- Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety in the first 28-Days of Therapy

Outcome Description:

The primary endpoint is evaluation of safety during the first 28-day cycle of therapy following the initiation of multiple dosing of HMPL-013. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate.

Outcome Time Frame:

28-Days after Permanent Discontinuation of HMPL-013

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

December 2012

Related Keywords:

  • Tumor