OncoMatch/Clinical Trials/NCT04771520
Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
Is NCT04771520 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Avapritinib for anatomic stage iv breast cancer ajcc v8.
Treatment: Avapritinib — This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Gastric Cancer
Esophageal Carcinoma
Tumor Agnostic
Melanoma
Sarcoma
Colorectal Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KIT pathogenic activating mutation
Documented pathogenic CKIT activating mutation (Cohort 1)
Required: PDGFRA pathogenic activating mutation
pathogenic PDGFRA activating mutation (Cohort 2)
Required: KIT pathogenic activating mutation
Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation/amplification
Required: KIT amplification
Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation/amplification
Required: PDGFRA pathogenic activating mutation
Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation/amplification
Required: PDGFRA amplification
Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation/amplification
Required: IDH1 wild-type
newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma
Required: MGMT unmethylated
newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma
Excluded: KIT V654A
Patients with tyrosine kinase inhibitor-resistant CKIT mutation V654A or T670I [excluded]
Excluded: KIT T670I
Patients with tyrosine kinase inhibitor-resistant CKIT mutation V654A or T670I [excluded]
Disease stage
Required: Stage III, IV
locally advanced or metastatic solid tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — concurrent with temozolomide (Cohort 3 only)
Patients must have received prior treatment with radiation and concurrent temozolomide per standard of care. Patients must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.
Cannot have received: tyrosine kinase inhibitor
Exception: CKIT mutation V654A or T670I
Patients with tyrosine kinase inhibitor-resistant CKIT mutation V654A or T670I [excluded]
Cannot have received: anticancer chemotherapy
Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation
Cannot have received: hormone therapy
Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation
Cannot have received: immunotherapy
Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation
Cannot have received: targeted therapy
Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation
Cannot have received: radiation therapy
Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation
Cannot have received: surgery
Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation
Cannot have received: intracerebral agent
Exception: Cohort 3 only
Prior treatment with an intracerebral agent or bevacizumab (Cohort 3 only)
Cannot have received: bevacizumab (bevacizumab)
Exception: Cohort 3 only
Prior treatment with an intracerebral agent or bevacizumab (Cohort 3 only)
Cannot have received: radiation therapy
Exception: for low-grade glioma (Cohort 3 only)
Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only)
Cannot have received: chemotherapy
Exception: for low-grade glioma (Cohort 3 only)
Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only)
Cannot have received: immunotherapy
Exception: for low-grade glioma (Cohort 3 only)
Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only)
Lab requirements
Blood counts
White blood cell count >2,500/µL and <15,000/µL; ANC ≥1.5 × 10^9/L (no G-CSF support within 2 weeks); Platelet count ≥75 × 10^9/L (no transfusion within 2 weeks); Hemoglobin ≥9.0 g/dL (no transfusion within 7 days).
Kidney function
Serum creatinine ≤2.0 × ULN or creatinine clearance ≥45 mL/min.
Liver function
Total bilirubin ≤1.5 × ULN; if hepatic metastases are present, ≤3.0 × ULN. AST and ALT ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN.
Cardiac function
Cardiac ejection fraction >45% per screening echocardiogram or MUGA scan. QTcF ≤470 msec.
Adequate organ and marrow function as defined below within 7 days of study treatment initiation: ... Cardiac ejection fraction >45% per screening echocardiogram or multigated acquisition scan. QT interval corrected using Fridericia's formula of >470 msec [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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