Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial

Sponsor
Peking University People's Hospital
Study ID
NCT03104335
Phase
PHASE2
Status
Withdrawn

Conditions

  • Advanced Cancer
  • Soft Tissue Sarcoma Adult

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    750 mg daily once oral administration of apatinib for body surface area (BSA) \> 1.5 and 500mg daily for BSA \<1.5. Half an hour after meal and everyday at the same time is usually advised.

Study Details

Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who experience progression after standard chemotherapy, have limited treatment options which promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly selective inhibitor of vascular endothelial growth factor receptor-2, as a treatment option for heavily pretreated soft tissue sarcoma patients.

Key Dates

Start date
Apr 1, 2017
Status verified
May 2020
Primary completion
Jun 30, 2019
Completion
Mar 1, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study arm
    every participant will recieve 750 mg daily once oral administration of apatinib for body surface area (BSA) \> 1.5 and 500mg daily for BSA \<1.5. Half an hour after meal and everyday at the same time is usually advised.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 4 months ]

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