Malignant Adrenal Gland PheochromocytomaPhase 2NCT04860700
The Efficacy and Safety of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma
A Phase 2 study testing anlotinib hydrochloride in people with Malignant Adrenal Gland Pheochromocytoma and Malignant Paraganglioma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma, Pheochromocytoma, Metastatic
- What is being tested?
- anlotinib hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 17 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 1）Absolute granulocyte count (AGC) greater than 1.5 x 109/L; 2）Platelet count greater than 80 x 109/L; 3) Hemoglobin greater than 90g/L; 4) Serum bilirubin less than 1.5 x upper limit of normal (ULN); 5)Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; 6) Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min; 7.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
Who cannot join
- 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.
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- 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).
- Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment.
- Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders.
- Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
- Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE grade 3, unhealed wounds, ulcers or fractures.
- Participated in other clinical trials within 4 weeks.
- Patients are using drugs that interact with Anlotinib.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Phase 2 Study of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma
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.
Read the detailed description
PRIMARY OBJECTIVES:
To determine the anti-tumor activity of anlotinib hydrochloride (Objective Response rate,ORR) in patients with metastatic pheochromocytomas or paragangliomas.
SECONDARY OBJECTIVES:
- To assess safety profile of anlotinib. II. To assess progression-free survival time. III. To assess disease control rate.
OUTLINE:
Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo urine and blood sample collection, imaging examinations at baseline and periodically during study.
After completion of study therapy, patients are followed up every 3-6 months.
- Conditions
- Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma, Pheochromocytoma, Metastatic, Paraganglioma, Malignant, Paraganglioma, Extra-Adrenal
- Being tested
- anlotinib hydrochloride
- Keywords
- pheochromocytoma, paraganglioma, Metastatic, inoperable
- Medical subject headings
- Paraganglioma, Extra-Adrenal, Pheochromocytoma, Neoplasm Metastasis, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinib hydrochlorideDrug
Also called anlotinib
Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib hydrochloride | Experimental | Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response rate RECIST Using Version 1.1
Defined for all patients whose tumor met the criteria of Complete Response (CR)and Partial Response (PR)
Measured: minimum of 4 cycles
Secondary outcomes (1)
Disease Control Rate
Defined for all patients whose tumor met the criteria of CR or PR or stable disease(SD)
Measured: minimum of 4 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start30 Apr 2021
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Adrenal Gland PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anli Tong, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860700
- Sponsor's protocol ID
- PUMCHMPPGL
- Status last verified
- Apr 2023
- First submitted
- 22 Apr 2021
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Anlotinib in Patients With Metastatic Pheochromocytoma or Paraganglioma
- ClinicalTrials.gov ID
- NCT04860700
- Acronym / sponsor ID
- PUMCHMPPGL
- Conditions
- Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma, Pheochromocytoma, Metastatic, Paraganglioma, Malignant, Paraganglioma, Extra-Adrenal
- Keywords
- pheochromocytoma, paraganglioma, Metastatic, inoperable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
To determine the anti-tumor activity of anlotinib hydrochloride (Objective Response rate,ORR) in patients with metastatic pheochromocytomas or paragangliomas.
SECONDARY OBJECTIVES:
- To assess safety profile of anlotinib. II. To assess progression-free survival time. III. To assess disease control rate.
OUTLINE:
Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo urine and blood sample collection, imaging examinations at baseline and periodically during study.
After completion of study therapy, patients are followed up every 3-6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib hydrochloride | Experimental | Drug: anlotinib hydrochloridePatients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anlotinib hydrochlorideAlso: anlotinibPatients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | Drug | anlotinib hydrochloride |
Primary outcome
Objective Response rate RECIST Using Version 1.1
Time frame: minimum of 4 cycles
Defined for all patients whose tumor met the criteria of Complete Response (CR)and Partial Response (PR)
1 secondary outcome
Disease Control Rate
Time frame: minimum of 4 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anli Tong principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anlotinib hydrochloride in people with Malignant Adrenal Gland Pheochromocytoma and Malignant Paraganglioma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response rate RECIST Using Version 1.1 (time frame: minimum of 4 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.