The Efficacy and Safety of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma (NCT04860700) | Clinical Trial Compass
CompletedPhase 2
The Efficacy and Safety of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma
China27 participantsStarted 2021-04-30
Plain-language summary
This phase II trial studies how well anlotinib hydrochloride works in treating patients with metastatic pheochromocytoma or paraganglioma. Anlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent.
✓. Willing to return to enrolling institution for follow-up.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
✓. Life expectancy \> 3 months.
✓. Patients diagnosis with metastatic pheochromocytoma or paraganglioma that is unresectable.
✓. Laboratory requirements:
Exclusion criteria
✕. Any of the following:Pregnant women,Nursing women,Men or women of childbearing potential who are unwilling to employ adequate contraception.
✕. Patients who have previously used other anti-vascular targeted drugs, such as sunitinib, bevacizumab, endurance, etc.
✕. Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery within 4 weeks prior to kinase inhibitor therapy.
✕. Patients with another primary malignancy within 5 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer).
✕. Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
. Patients with known untreated brain metastases are excluded. Patients having a history of brain metastasis that have been previously irradiated or resected greater than 2 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment. Patients with brain metastases with symptoms or symptom control for less than 2 months.
✕. Active or uncontrolled intercurrent illness including, but not limited to 1)Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); 2) Patients with uncontrolled myocardial ischemia or myocardial infarction, arrhythmia (including QTC≥480ms), and uncontrolled congestive heart failure，grade ≥2（New York Heart Association ）; 3) ongoing or active infection; 4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7) Diabetes is poorly controlled (fasting blood glucose (FBG)\> 10mmol/L); 8) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein content is confirmed to be greater than 1.0 g; 9) Patients who have seizures and need treatment;
✕. Any of the following conditions =\< 6 months prior to registration: Cerebrovascular accident (CVA) or transient ischemic attack (TIA); Serious or unstable cardiac arrhythmia; Pulmonary embolism, untreated deep venous thrombosis (DVT).