Actively Recruiting
Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-03-02
50
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the study.
- Male or female aged 18 years or older at consent; adolescents 12 years and older allowed with assent and parental consent.
- Have a locally advanced or metastatic solid tumor that has progressed on or lacks effective standard therapy, or have declined standard therapy.
- Newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma patients who completed radiation and temozolomide 3-8 weeks prior.
- Measurable disease per RECIST v1.1 or RANO criteria (Cohorts 1 and 2); measurable or non-measurable disease for Cohort 3.
- Documented pathogenic CKIT or PDGFRA activating mutation based on certified next-generation sequencing.
- Available archival tissue for mutation testing.
- Adequate organ and marrow function within 7 days before treatment.
- Cardiac ejection fraction above 45%.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Life expectancy of at least 3 months.
- Willing and able to comply with study protocol and visits.
- Agree to biopsy as required.
- Females must be postmenopausal, surgically sterile, or use effective contraception; males with partners of reproductive potential must use effective contraception or abstain.
You will not qualify if you...
- Diagnosis of gastrointestinal stromal tumor (GIST).
- Resistant CKIT mutations V654A or T670I.
- Meningeal carcinomatosis, spinal cord compression, or symptomatic/unstable brain metastases.
- History of severe heart failure or serious arrhythmias.
- Corrected QT interval greater than 470 msec.
- Participation in other investigational studies or use of investigational devices within 2 weeks before treatment.
- Recent anticancer therapies or surgery within 2 weeks before treatment, with specific recovery requirements.
- Symptomatic non-healing wounds, ulcers, gastrointestinal perforation, or bone fractures.
- History of psychotic or depressive disorders unless well controlled for at least 12 months.
- Use of strong CYP3A4 inhibitors or inducers without required washout.
- Pregnancy or breastfeeding.
- Unable to swallow or retain oral medications.
- Gastrointestinal conditions that affect absorption.
- Additional progressing malignancy requiring treatment, except certain skin or cervical cancers.
- Any condition or lab abnormality that interferes with study participation or safety.
- Prior intracerebral agent or bevacizumab treatment (Cohort 3).
- Prior treatment for low-grade glioma (Cohort 3).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jordi R Rodon, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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