CompletedPhase 2

Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS)

China40 participantsStarted 2022-08-25

Plain-language summary

This is a Phase 2, single-arm, open-label study in patients with advanced or unresectable soft tissue sarcoma.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male or female, age ≥ 18 years and ≤75 years.
✓. Histologically confirmed advanced or unresectable soft tissue sarcoma with failure of standard therapy or no standard therapy.
✓. At least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
✓. Laboratory criteria are as follows:
✓. Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥75×109/L, hemoglobin ≥80 g/L.
✓. Biochemistry: serum creatinine \<1.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN, both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for patients with hepatic metastasis).
✓. Coagulation panel: international normalized ratio (INR) \<1.5.

Exclusion criteria

✕. Active central nervous system (CNS) symptoms during the screening period and/or CNS metastases requiring hormone therapy within 28 days before the first dose, or lesions involving the brain stem or pia mater.
✕. Imaging during the screening period showed that the tumor had invaded the periphery of the important blood vessels or the investigator judged that the tumor was likely to invade the important blood vessels and cause massive bleeding during the trial.
✕. Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period.
✕. Current or previous history of other malignancies (other than adequately treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless curative treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
✕. Prior treatment with vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors (For patients eligible for anlotinib, only those who could not receive anlotinib for various reasons were allowed to be enrolled in this study. Patients who had previously received anlotinib were excluded from the study).
✕. Anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy and targeted therapy were used within 28 days before the first treatment.
✕. Allergic or contraindicated to any component or vehicle of the test drug.
✕. Treatment with an investigational agent/instrument within 28 days prior to first dose.

What they're measuring

Progression-free survival of 12 weeks(PFS12w)

Timeframe: 12 weeks after the first dose

Trial details

NCT IDNCT05497843

SponsorChipscreen Biosciences, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-03

View on ClinicalTrials.gov More Soft Tissue Sarcoma trials