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Avapritinib for Advanced Solid Tumors with CKIT or PDGFRA Mutations

This study is testing avapritinib in people with locally advanced or metastatic (spread to other parts of the body) solid tumors that have specific genetic changes called CKIT or PDGFRA mutations. Avapritinib is a drug given by mouth that may work by blocking certain enzymes that help cancer cells grow. Researchers want to see if avapritinib can shrink these tumors or stop their growth. The main goal is to measure how many patients respond to the treatment. The study is currently enrolling a planned 50 participants aged 18 and older, including adolescents 12 and up with parental consent.

Study design
This is an interventional study planning to enroll 50 participants. It is testing the drug avapritinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed for up to 50 months, or until the date of death, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04771520

Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Avapritinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over or date of death from any cause, whichever came first, assessed up to 50 months

Conditions

Anatomic Stage IV Breast Cancer AJCC v8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Locally Advanced Malignant Solid Neoplasm
Locally Advanced Melanoma
Locally Advanced Primary Malignant Central Nervous System Neoplasm
Locally Advanced Sarcoma
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Primary Malignant Central Nervous System Neoplasm
Metastatic Sarcoma
Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage IV Breast Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8

Explore related trials

Breast CarcinomaCentral Nervous System NeoplasmColorectal CarcinomaGastroesophageal Junction AdenocarcinomaGlioblastomaLung CarcinomaMelanomaSarcomaSolid NeoplasmKIT wt AllelePDGFRA Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jordi Rodon Ahnert · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Jordi R Rodon, MD, PHD
[email protected]
(713) 792-5603
Email the study team

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Eligibility criteria

Inclusion

White blood cell count \>2,500/µL and \<15,000/µL
Absolute neutrophil count ≥1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
Platelet count ≥75 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
Hemoglobin ≥9.0 g/dL (without blood transfusion within 7 days of laboratory test used to determine eligibility)
Total bilirubin ≤1.5 × upper limit of normal (ULN); if hepatic metastases are present, ≤3.0 × ULN
Aspartate transaminase and alanine transaminase ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN
Serum creatinine ≤2.0 × ULN or creatinine clearance ≥45 mL/min. 9. Cardiac ejection fraction \>45% per screening echocardiogram or multigated acquisition scan.

Exclusion

NOTE: Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline (except alopecia). Patients with ≤ Grade 2 neuropathy are eligible.
NOTE: If patient received major surgery, she/he must have recovered adequately from the toxicity and/or complications from the intervention prior to study treatment initiation.
NOTE: Patients in Cohort 3 must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation. 8. Symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture. 9. History of psychotic or depressive disorder. Patients whose disorder is well controlled on a stable antipsychotic or antidepressant medication for at least 12 months prior to study entry will be eligible. 10. Concomitant use of a known strong cytochrome P450 (CYP)3A4 inhibitor or strong CYP3A4 inducer. The required washout period prior to study treatment initiation is 2 weeks or 5 half-lives, whichever is shortest. 11. Females who are pregnant or breastfeeding. 12. Unable to swallow and retain oral medications. 13. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 14. Known additional malignancy that is progressing or requires active treatment. NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded. 15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator. 16. Prior treatment with an intracerebral agent or bevacizumab (Cohort 3 only). 17. Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only).

What this trial measures

  • Overall response rate (ORR)or date of death from any cause, whichever came first, assessed up to 50 months

    ORR defined as confirmed complete response (CR) or partial response (PR) from the time of study treatment initiation until disease progression as centrally assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology Criteria (RANO) criteria, as appropriate. Confirmed CR or PR will be defined as a repeat assessment performed 4 weeks (+/-3 days) after the criteria for response is first met. Will estimate ORR along with 90% confidence interval according to Clopper-Pearson method for each cohort and for specific tumor type.