Your session is about to expire
← Back to Search
Somatostatin Analog
Lanreotide for Pheochromocytoma / Paraganglioma (LAMPARA Trial)
Phase 2
Recruiting
Led By Antonio Fojo, MD, PhD
Research Sponsored by Antonio Fojo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 32 weeks, up to 48 weeks
Awards & highlights
LAMPARA Trial Summary
This trial will assess the efficacy of lanreotide given every 4 weeks in participants with advanced or metastatic paraganglioma/pheochromocytoma.
Eligible Conditions
- Pheochromocytoma
- Paraganglioma
LAMPARA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum of 32 weeks, up to 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 32 weeks, up to 48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of tumor growth
Secondary outcome measures
Magnitude of change in analyte levels
Overall Response Rate (ORR)
Overall survival (OS)
+1 moreSide effects data
From 2015 Phase 3 trial • 115 Patients • NCT0077493023%
Abdominal pain
16%
Fatigue
14%
Diarrhoea
14%
Back pain
12%
Abdominal pain upper
12%
Hyperglycaemia
12%
Nasopharyngitis
11%
Asthenia
11%
Anaemia
11%
Arthralgia
9%
Disease progression
9%
Decreased appetite
9%
Constipation
9%
Vomiting
9%
Headache
9%
Gamma-glutamyltransferase increased
9%
Pyrexia
9%
Hypertension
7%
Nausea
7%
Blood triglycerides increased
7%
Musculoskeletal pain
7%
Pain in extremity
7%
Cholelithiasis
5%
Gout
5%
Hypertriglyceridaemia
5%
Hot flush
5%
Blood creatine phosphokinase increased
5%
Intervertebral disc protrusion
5%
Aspartate aminotransferase increased
5%
Flushing
5%
Hypoglycaemia
5%
Oedema peripheral
5%
Upper respiratory tract infection
5%
Anxiety
5%
Cough
5%
Influenza like illness
4%
Dyspnoea
4%
Dizziness
4%
Malignant neoplasm progression
4%
Sepsis
2%
Patella fracture
2%
Tumour necrosis
2%
Pyelonephritis acute
2%
Urosepsis
2%
Ureteric stenosis
2%
Infection
2%
Syncope
2%
Pneumonia aspiration
2%
Pyelonephritis
2%
Femur fracture
2%
Pneumothorax
2%
Subileus
2%
Death
2%
General physical health deterioration
2%
Glucose tolerance impaired
2%
Muscle spasms
2%
Urinary tract infection
2%
Kidney infection
2%
Sciatica
2%
Pancreatic carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)
Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)
Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)
Placebo (DB Phase)
LAMPARA Trial Design
1Treatment groups
Experimental Treatment
Group I: lanreotide armExperimental Treatment1 Intervention
Patients with a histopathologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability who meet the inclusion/exclusion criteria. Approximately 40 patients will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanreotide
2009
Completed Phase 3
~600
Find a Location
Who is running the clinical trial?
Antonio FojoLead Sponsor
2 Previous Clinical Trials
5 Total Patients Enrolled
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,188 Total Patients Enrolled
1 Trials studying Pheochromocytoma
93 Patients Enrolled for Pheochromocytoma
Antonio Fojo, MD, PhDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a heart attack, unstable chest pain, or worsening heart failure in the last 28 days.You are able to carry out everyday activities without needing help.Your blood counts and liver function need to be within specific ranges.You have a known allergy to the investigational drug or similar medications like Lanreotide or octreotide.You have taken any experimental medication or strong chemotherapy within the last 28 days before starting the study or during the study.You have had treatment with certain medications or procedures too close to the start of the study.You have received a specific type of treatment for liver cancer less than 28 days before starting the study. The cancer must be present in areas of the body other than where the treated lesions are located.You received a certain type of liver treatment within the last 90 days, and you must have a specific type of disease outside the liver to participate.Your diabetes or high blood pressure has not been well controlled with medication in the past 28 days.Your kidneys don't work well (glomerular filtration rate less than 30 ml/min/1.73m2) or your liver isn't working properly (serum total bilirubin greater than 1.5 x ULN, or greater than 2.5 x ULN if you have cancer spread to the liver).You had cancer in the past, but it was treated and you have been cancer-free for at least 2 years, or you have certain types of non-invasive cancers.You have been diagnosed with malignant paraganglioma or pheochromocytoma and it has spread to other parts of the body or cannot be removed with surgery.Your disease has gotten worse recently, even though you weren't on any treatment or the treatment you were on didn't work.You have a visible disease that can be measured and have had at least three X-rays or scans in the past year, with at least one taken in the last six weeks before joining the study.You need to have had a test in the last 6 months that shows you have a positive somatostatin receptor status. If you haven't had this test in the last 6 months, you will need to have it before joining the study. If you need to have the test, it will be done at least 24 hours after getting a shot of octreotide.You have not previously received certain medications for your condition.You are expected to live for at least 12 more weeks.Your blood clotting tests should be within a certain range.If you had radiation treatment, you need to wait at least 42 days before joining the study. Any measurable disease must be outside the area where you had radiation.
Research Study Groups:
This trial has the following groups:- Group 1: lanreotide arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies is Lanreotide most typically prescribed for?
"Lanreotide has been clinically demonstrated to effectively address unresectable, metastatic enteropancreatic neuroendocrine tumors, neoplasm metastasis and advance directives."
Answered by AI
What potential risks might be posed by administering Lanreotide?
"Our risk assessment of Lanreotide has determined it to be a score 2, due to the fact that there is only limited evidence on its safety but none attesting to its efficacy."
Answered by AI
Are there any prior examples of Lanreotide being tested in a clinical setting?
"Lanreotide was first investigated in 2016 at Massachusetts General Hospital, and has since been the subject of 39 trials. Currently 8 clinical studies are ongoing, several of which take place in Cleveland, Ohio."
Answered by AI
To what extent is the participant pool for this medical experiment increasing?
"Affirmative. According to clinicaltrials.gov, this medical experiment has been accepting enrolments since June 17th 2019 and the last update was October 5th 2022. 40 participants across 3 different centres are needed for completion of the study."
Answered by AI
Is this an innovative clinical trial?
"An extensive number of trials have been conducted for the drug Lanreotide. Since 2016, 8 ongoing experiments in 26 cities and 14 countries are underway to confirm its efficacy. Eli Lilly and Company launched an initial study involving 44 people which achieved Phase 2 approval that same year; since then, a further 39 studies have concluded with successful results."
Answered by AI
Are there any openings available for participants in this clinical examination?
"Affirmative. The information on clinicaltrials.gov indicates that this research is actively seeking participants, with the initial posting occurring in June of 2019 and the most recent update being October 5th 2022. 40 individuals will be admitted to 3 separate sites for participation purposes."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger