Advanced or Metastatic Paraganglioma/ PheochromocytomaPhase 2EASOAIPPGLNCT05133349
A Prospective Phase II Efficacy and Safety Study of Anlotinib in Metastatic or Locally Advanced Pheochromocytoma/ Paraganglioma : Open-label Single-arm, Exploratory Trial
A Phase 2 study testing Anlotinib in people with Advanced or Metastatic Paraganglioma/ Pheochromocytoma, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This is an open-label phase II study of an investigational drug, anlotinib in participants with advanced malignant paraganglioma or pheochromocytoma. Pheochromocytoma and paraganglioma (PPGL) are tumors originating from the adrenal medulla or adrenal diplomatic sensory chain, respectively, which can synthesize and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced or Metastatic Paraganglioma/ Pheochromocytoma
- What is being tested?
- Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2021to 30 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with advanced, metastatic, recurrent or unresectable pheochromocytoma or paraganglioma. Pathology report or pathology slides (H\&E) confirming histological diagnosis must be available at the time of enrollment.
- Must have measurable disease by RECIST v1.1.
- ECOG performance status 0-2, life expectancy of at least 6 months
- Adequate organ and marrow function was required (hemoglobin >= 8.0 g/dL (5.6 mmol/L); absolute neutrophil count (ANC) >= 1500/mm^3; platelet count >= 80,000/mm^3; creatinine =< 1.5 x ULN or creatinine clearance rate (CCr) ≥60ml/min, blood urea nitrogen (BUN) ≤2.5 × upper limit of normal (ULN); total bilirubin (TB) =< 1.5 X ULN; aspartate transaminase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN (if there are liver metastases, <= 5 x ULN); albumin (ALB) ≥25 g/L; urine protein/creatinine ratio =< 1 OR 24-hour urine protein < 1.5 gram)
- Blood pressure (BP) < 150 mmHg (systolic) and < 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 150/90 mmHg; NOTE: all patients with secretory pheochromocytoma or paraganglioma are REQUIRED to: 1) be evaluated in consultation by a hypertension specialist with specific experience in the management of hypertension in the setting of catecholamine-secreting tumors (usually an endocrinologist, nephrologist, or a cardiologist), and in the setting of hormone-associated hypertension) receive alpha- and beta-adrenergic blockade for at least 7-14 days prior to initiation of anlotinib; the hypertension specialist of record for each patient should be committed to closely following the patient during the clinical study with evaluation by said specialist required at cycle 1 and 2 and thereafter on an as needed basis.
- Age greater or equal to 18 years old
- Participants who give a written informed consent obtained according to institutional guidelines
- Ability to complete questionnaire(s) by themselves or with assistance
Who cannot join
- Participants who have received bevacizumab, sunitinib, sorafenib, or pazopanib less than or equal to 2 weeks prior to starting study drug, or who have not recovered (grade 1) from the side effects of these therapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to anlotinib.
- Participants who have many influence factors toward oral medications
- Participants receiving concurrent treatment with other anti-cancer therapy chemotherapy/systemic therapy, radiotherapy, or immunotherapy =< 28 days prior to registration) given for paraganglioma or pheochromocytoma or failure to recover from toxicities. NOTE: concurrent therapy with octreotide is allowed providing that tumor progression on this therapy has been demonstrated; concurrent therapy with bisphosphonates (e.g. zoledronic acid) or denosumab is also allowed; There is no limit to the number of prior chemotherapy or biotherapy
- Participants with known untreated brain metastases are excluded. Participants having a history of brain metastasis that have been previously irradiated or resected greater than 3 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment.
- Participants with another primary malignancy within 2 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)，also with the exception of other primary malignancy caused by related genetic diseases, such as VHL.
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- Participants who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury less than or equal to 4 weeks prior to starting study drug, or participants who have had minor procedures, percutaneous biopsies or placement of vascular access device 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Participants with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study (i.e. suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure; activity or failure to control severe infections; liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis; poorly controlled diabetes (FBG)>10mmol/L); urine protein≥++, etc.)
- Participants with any of the following conditions =< 6 months prior to registration: Cerebrovascular accident (CVA) or transient ischemic attack (TIA) Serious or unstable cardiac arrhythmia Admission for unstable angina or myocardial infarction Cardiac angioplasty or stenting Coronary artery bypass graft surgery Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation =< 30 days Arterial thrombosis Symptomatic peripheral vascular disease
- Participants failed to heal wounds or fractures for Long-term
- Participants have HIV-positive or organ transplantation
- Pregnant or breastfeeding women or any subjects who refuse to use protocol required contraception
- Participants unwilling or unable to comply with the protocol
- Investigators consider that there are any conditions that may cause the participants to fail to perform study requirements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical Univerity
Nanjing, Jiangsu, 210006
Feng Wang, 02552271491, fengwangcn@hotmail.com
RUI TIAN, 02552271491, ruitian_nm@163.com
About this study
Official title: A Prospective Phase II Efficacy and Safety Study of Anlotinib in Metastatic or Locally Advanced Pheochromocytoma/ Paraganglioma : Open-label Single-arm, Exploratory Trial.
This is an open-label phase II study of an investigational drug, anlotinib in participants with advanced malignant paraganglioma or pheochromocytoma. Pheochromocytoma and paraganglioma (PPGL) are tumors originating from the adrenal medulla or adrenal diplomatic sensory chain, respectively, which can synthesize and secrete large amounts of catecholamines. In this study, participants whose disease has advanced or spread despite prior standard therapy, will receive anlotinib for 2-weeks followed by a 1-week rest period, until disease progression (PD) or drug toxicity intolerance. Anlotinib is an investigational drug, which has been shown to shrink tumours in several tumour models. The study will evaluate the efficacy as well as the toxicity profile of anlotinib when used as an alternative treatment for participants with PPGL tumours.
Read the detailed description
This study will be a single arm, open-label, phase II trial of anlotinib in participants with metastatic or locally advanced malignant pheochromocytoma or paraganglioma. Oral anlotinib (12 mg) will be administered to all participants daily for the first 2 weeks of a 3-week study cycle, followed by a 1 week rest. Participants will be assessed for response to study treatment using MRI/CT scans as well as bio-chemical tests, and will receive the study treatment for up to 12 months or until disease progression.
- Being tested
- Anlotinib
- Keywords
- Anlotinib, paraganglioma, pheochromocytoma
- Medical subject headings
- Paraganglioma, Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Anlotinib 12mg capsules given orally on once daily in 21-day cycle until disease progression or treatment intolerance(14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21), the dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Anlotinib 12mg capsules given orally on once daily in 21-day cycle until disease progression or treatment intolerance(14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21), the dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient. Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Time
Measured: 2 years
Secondary outcomes (2)
Overall response rate (PR) + (CR)
Measured: 2 years
Incidence of adverse events
Incidence of adverse events assessed by Common Terminology Criteria for Adverse safety profile of anlotinib
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start14 Sep 2021
- Primary completion14 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Paraganglioma/ PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133349
- Sponsor's protocol ID
- ATPP
- Acronym
- EASOAIPPGL
- Status last verified
- Sep 2021
- First submitted
- 17 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Efficacy and Safety Study of Anlotinib in Metastatic or Locally Advanced Pheochromocytoma/ Paraganglioma : Open-label Single-arm, Exploratory Trial.
- ClinicalTrials.gov ID
- NCT05133349
- Acronym / sponsor ID
- EASOAIPPGL / ATPP
- Keywords
- Anlotinib, paraganglioma, pheochromocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 14 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 Nov 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 is an open-label phase II study of an investigational drug, anlotinib in participants with advanced malignant paraganglioma or pheochromocytoma. Pheochromocytoma and paraganglioma (PPGL) are tumors originating from the adrenal medulla or adrenal diplomatic sensory chain, respectively, which can synthesize and secrete large amounts of catecholamines. In this study, participants whose disease has advanced or spread despite prior standard therapy, will receive anlotinib for 2-weeks followed by a 1-week rest period, until disease progression (PD) or drug toxicity intolerance. Anlotinib is an investigational drug, which has been shown to shrink tumours in several tumour models. The study will evaluate the efficacy as well as the toxicity profile of anlotinib when used as an alternative treatment for participants with PPGL tumours.
Detailed description
This study will be a single arm, open-label, phase II trial of anlotinib in participants with metastatic or locally advanced malignant pheochromocytoma or paraganglioma. Oral anlotinib (12 mg) will be administered to all participants daily for the first 2 weeks of a 3-week study cycle, followed by a 1 week rest. Participants will be assessed for response to study treatment using MRI/CT scans as well as bio-chemical tests, and will receive the study treatment for up to 12 months or until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: AnlotinibAnlotinib 12mg capsules given orally on once daily in 21-day cycle until disease progression or treatment intolerance(14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21), the dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with advanced, metastatic, recurrent or unresectable pheochromocytoma or paraganglioma. Pathology report or pathology slides (H\&E) confirming histological diagnosis must be available at the time of enrollment.
- Must have measurable disease by RECIST v1.1.
- ECOG performance status 0-2, life expectancy of at least 6 months
- Adequate organ and marrow function was required (hemoglobin >= 8.0 g/dL (5.6 mmol/L); absolute neutrophil count (ANC) >= 1500/mm^3; platelet count >= 80,000/mm^3; creatinine =< 1.5 x ULN or creatinine clearance rate (CCr) ≥60ml/min, blood urea nitrogen (BUN) ≤2.5 × upper limit of normal (ULN); total bilirubin (TB) =< 1.5 X ULN; aspartate transaminase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN (if there are liver metastases, <= 5 x ULN); albumin (ALB) ≥25 g/L; urine protein/creatinine ratio =< 1 OR 24-hour urine protein < 1.5 gram)
- Blood pressure (BP) < 150 mmHg (systolic) and < 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 150/90 mmHg; NOTE: all patients with secretory pheochromocytoma or paraganglioma are REQUIRED to: 1) be evaluated in consultation by a hypertension specialist with specific experience in the management of hypertension in the setting of catecholamine-secreting tumors (usually an endocrinologist, nephrologist, or a cardiologist), and in the setting of hormone-associated hypertension) receive alpha- and beta-adrenergic blockade for at least 7-14 days prior to initiation of anlotinib; the hypertension specialist of record for each patient should be committed to closely following the patient during the clinical study with evaluation by said specialist required at cycle 1 and 2 and thereafter on an as needed basis.
Key exclusion criteria (14 listed)
- Participants who have received bevacizumab, sunitinib, sorafenib, or pazopanib less than or equal to 2 weeks prior to starting study drug, or who have not recovered (grade 1) from the side effects of these therapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to anlotinib.
- Participants who have many influence factors toward oral medications
- Participants receiving concurrent treatment with other anti-cancer therapy chemotherapy/systemic therapy, radiotherapy, or immunotherapy =< 28 days prior to registration) given for paraganglioma or pheochromocytoma or failure to recover from toxicities. NOTE: concurrent therapy with octreotide is allowed providing that tumor progression on this therapy has been demonstrated; concurrent therapy with bisphosphonates (e.g. zoledronic acid) or denosumab is also allowed; There is no limit to the number of prior chemotherapy or biotherapy
- Participants with known untreated brain metastases are excluded. Participants having a history of brain metastasis that have been previously irradiated or resected greater than 3 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment.
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 |
|---|---|---|
| AnlotinibAnlotinib 12mg capsules given orally on once daily in 21-day cycle until disease progression or treatment intolerance(14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21), the dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient. | Drug | Anlotinib |
Primary outcome
Progression-free Survival Time
Time frame: 2 years
2 secondary outcomes
Overall response rate (PR) + (CR)
Time frame: 2 years
Incidence of adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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.
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 in people with Advanced or Metastatic Paraganglioma/ Pheochromocytoma, run by Nanjing First Hospital, Nanjing Medical University 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 8 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (02552271491, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival Time (time frame: 2 years). 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 24 Nov 2021.