Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Pheochromocytoma

Paraganglioma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Paragangliomas 1

Neuroepithelioma

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Amino Acids

Endothelial Growth Factors

Mitogens

Iodine

Cadexomer iodine

Tyrosine

Vandetanib (100, 200 or 300 mg once daily) in combination with 131I-mIBG radiation therapy (activity to be prescribed to deliver whole body absorbed dose of 0.5 Gy) on day 1 of each 12-weekly cycle.

Patients will receive up to 4 cycles of vandetanib in combination with 131I-mIBG.

100 mg, 200 mg or 300 mg taken once a day during each 12-weekly cycle

Vandetanib

Activity will be prescribed to deliver whole body absorbed dose of 0.5 Gy (+/-10%)

131I-mIBG

Christina Thirlwell

The phase I trial aims to determine the recommended phase II dose (RP2D) of vandetanib in combination with standard radiation therapy, 131I-mIBG, in patients with advanced phaeochromocytoma (phaeo) and paraganglioma (PG) by assessing the safety and tolerability of the combination treatment.

VIBRaNT is a registered phase I trial in patients with locally advanced or metastatic phaeochromocytoma or paraganglioma, not amenable to surgical resection.

Patients will receive vandetanib (an inhibitor of VEGF, EGFR and RET tyrosine kinase) in combination with standard radiation therapy Iodine-131 labelled Meta-iodobenzylguanidine (131I-mIBG).

Vandetanib and 131I-mIBG will be given in 12-weekly cycles: 131I-miBG will be given on day 1 of each cycle and vandetanib will started on day 1 of each cycle and continue to be taken once every day. The phase I trial aims to determine with recommended phase II dose of vandetanib (either 100, 200 or 300 mg once daily) - the dose of vandetanib that patients will receive will depend on the dose under investigation at the time of patient registration.

The vandetanib dose will be determined by the Modified Continual Reassessment Method (mCRM) - a toxicity model which described the probability of a toxicity occurring at each dose level, which is based on clinical judgement and any available toxicity data.

Phase I Trial of Vandetanib Combined With 131I-mIBG to Treat Patients With Advanced Phaeochromocytoma and Paraganglioma

A Phase I Trial of Vandetanib Combined With 131I-mIBG Radiotherapy in Patients With Neuroendocrine Tumours, Advanced Phaeochromocytoma and Paraganglioma

Detailed adverse event monitoring will be conducted according to CTCAE v4.03. Dose Limiting Toxicity (DLT) is defined as any adverse event or laboratory abnormality detailed in the trial protocol, that is considered to be highly probable or probable trial treatment related and commencing anytime during the DLT evaluation period (from start of cycle 1 to cycle 1 week 12). Adverse Events include: Haematological, Clinical Chemistry, Cardiovascular, Gastrointestinal, Skin.

Response will be assessed according to RECIST v1.1. Confirmation of complete or partial response is not required. Stable disease will be considered the best response only is a second assessment has been carried out which confirmed stable disease at least 4 weeks after trial entry. Assessment will be determined using CT scans and 123I-mIBG scans performed at baseline, then every 3 months after start of treatment until disease progression (up to 3 years from registration)

Will include all grade 1-5 adverse events.

Progression-free survival will be calculated from the date of trial entry to the date of documented disease progression, or death from any cause. Where progression is suspected and subsequently confirmed by scans, the date of documented suspected progression will be used.

Cancer Research UK

AstraZeneca

University College, London

Carcinoid Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Antineoplastic Agents

Gastrointestinal Agents

Somatostatin

Lutetium Lu 177 dotatate

Octreotide

Antineoplastic Agents, Hormonal

Radiopharmaceuticals

* 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died.
* Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi).
* Concomitant amino acids were given with each administration for kidney protection.
* 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.
* In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.

* 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.
* In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.

In the experimental arm, 30 mg Octreotide LAR treatment was given to the participants until the end of study for symptom control purpose, unless the participant progressed or died.

In the active comparator arm, 60 mg Octreotide LAR treatment was given to the participants every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.

Octreotide LAR

Four administrations of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.

177Lu-DOTA0-Tyr3-Octreotate

Novartis Pharmaceuticals

This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutathera or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by tumor uptake score and by the length of time that a participant was on a constant dose of Octreotide (=\< 6 versus \> 6 months).

Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed:

1. Any participants with progressive disease (confirmed by central review of CT/MRI scans) ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety.
2. All non-progressive participants continued treatment/assessments until the PFS primary endpoint was met (i.e. 74 evaluable and centrally confirmed disease progressions or death events). Once the Primary End-Point was reached:

   1. Participants who received more than 76 weeks of treatment/assessment, stopped the study treatment (however somatostatin analogues could be received as subsequent treatment as per Investigator's discretion) but continued the long-term follow-up assessment for 5 years overall from the date of randomization of the last participant randomized.
   2. The remaining randomized participants continued in the fixed 76-week treatment/assessment period unless progression occurred, then continued the long-term follow-up assessments for 5 years overall from the date of randomization of the last participant.

A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) according to RECIST 1.1.

Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause or the date of last contact (censored observation) prior to the date of the data cut-off, and during the entire study period (i.e. the treatment period plus follow-up).

Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups.

Time to Tumour Progression (TTP) was defined as the time from randomization to progression centrally assessed. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).

The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression by RECIST 1.1.

The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.

The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.

Advanced Accelerator Applications

Any sign or symptom that occurs after written informed consent provided.

Total

Age, Continuous

Sex: Female, Male

Asian

Black or African American

Hispanic

White

Other

Not Applicable

Race/Ethnicity, Customized

Study Director

Progression Free Survival (PFS)

Full Analysis Set (FAS). Only participants with available post-baseline CT scans were considered.

Objective Response Rate (ORR)

Overall Survival (OS)

12 months

24 months

36 months

48 months

60 months

Rate of Overall Survival (OS)

Time to Tumour Progression (TTP)

Full Analysis Set (FAS). Only Participants with an Objective Response are included in the analysis.

Duration of Response (DoR)

Adverse Events (AEs)

Serious Adverse Events (SAEs)

Deaths during treatment period

Deaths during follow-up period

Number of Participants With Adverse Events

Physical functioning: chg from BL @ wk 72 (n=33,11)

Physical functioning: chg from BL @ wk 120 (n=2,0)

Role functioning: chg from BL @ wk 72 (n=33,11)

Role functioning: chg from BL @ wk 120 (n=2,0)

Emotional functioning: chg from BL @ wk 72 (n=33,11)

Emotional functioning: chg from BL @ wk 120 (n=2,0)

Cognitive functioning: chg from BL @ wk 72 (n=33,11)

Cognitive functioning: chg from BL @ wk 120 (n=2,0)

Social functioning: chg from BL @ wk 72 (n=33,11)

Social functioning: chg from BL @ wk 120 (n=2,0)

Global Health Status/QoL: chg from BL @ wk 72 (n=33,11)

Global Health Status/QoL: chg from BL @ wk 120 (n=2,0)

Fatigue: chg from BL @ wk 72 (n=33,11)

Fatigue: chg from BL @ wk 120 (n=2,0)

Nausea & Vomiting: chg from BL @ wk 72 (n=33,11)

Nausea & Vomiting: chg from BL @ wk 120 (n=2,0)

Pain: chg from BL @ wk 72 (n=33,11)

Pain: chg from BL @ wk 120 (n=2,0)

Dyspnoea: chg from BL @ wk 72 (n=33,11)

Dyspnoea: chg from BL @ wk 120 (n=2,0)

Insomnia: chg from BL @ wk 72 (n=33,11)

Insomnia: chg from BL @ wk 120 (n=2,0)

Appetite loss: chg from BL @ wk 72 (n=33,11)

Appetite loss: chg from BL @ wk 120 (n=2,0)

Constipation: chg from BL @ wk 72 (n=33,11)

Constipation: chg from BL @ wk 120 (n=2,0)

Diarrhoea: chg from BL @ wk 72 (n=33,11)

Diarrhoea: chg from BL @ wk 120 (n=2,0)

Financial difficulties: chg from BL @ wk 72 (n=33,11)

Financial difficulties: chg from BL @ wk 120 (n=2,0)

Safety Analysis Set (SAF). Values at Inclusion were taken from last non-missing value prior to randomization (the only scheduled pre-randomization assessment was at the Baseline visit). Calculations at each visit included only participants with scores at the visit and Inclusion.

Change From Baseline in the EORTC QLQ-C30 Questionnaire

Endocrine scale: chg from BL @ wk 72 (n=33,11)

Endocrine scale: chg from BL @ wk 120 (n=2,0)

G.I. scale: chg from BL @ wk 72 (n=33,11)

G.I. scale: chg from BL @ wk 120 (n=2,0)

Treatment scale: chg from BL @ wk 72 (n=21,5)

Treatment scale: chg from BL @ wk 120 (n=1,0)

Social function scale: chg from BL @ wk 72 (n=33,11)

Social function scale: chg from BL @ wk 120 (n=2,0)

Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)

Diseases rel. worries scale: chg from BL @ wk 120 (n=2,0)

Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)

Muscle/Bone pain symptom: chg from BL @ wk 120 (n=2,0)

Sexual function: chg from BL @ wk 72 (n=21,7)

Sexual function: chg from BL @ wk 120 (n=2,0)

Information/Communication: chg from BL @ wk 72 (n=33,11)

Information/Communication: chg from BL @ wk 120 (n=2,0)

Body image: chg from BL @ wk 72 (n=33,11)

Body image: chg from BL @ wk 120 (n=2,0)

Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)

Treatment Period

Long-term Follow-Up Period

Gastro-enteropancreatic Neuroendocrine Tumor

Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) Lutetium\[177Lu\] Oxodotreotide Injection: Four administrations of 7.4 GBq (200 mCi).

Concomitant amino acids were given with each administration for kidney protection.

Lutetium\[177Lu\] Oxodotreotide Injection was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.

In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.

60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.

In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.

Four administrations of 7.4 GBq (200 mCi) Lutetium\[177Lu\] Oxodotreotide Injection administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.

Lutetium[177Lu] Oxodotreotide Injection

60 mg Octreotide LAR treatment was given to the participants every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.

Shan Zhang

Jianming Xu

This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium\[177Lu\] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutetium\[177Lu\] Oxodotreotide Injection or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by primary site of tumor (pancreatic or non-pancreatic), NET pathological grading (G1 or G2) and by the length of time that a participant was on a constant dose of Octreotide (=\< 6 versus \> 6 months). Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: any participants with progressive disease ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety.

A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs

A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, , Well Differentiated， Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Blinded Independent Review Committee (BIRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the investigators, or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

DCR is defined as the incidence of complete response, partial response and stable disease according to RECIST v1.1.

20-month Progression-Free Survival was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the investigators, or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Sinotau Pharmaceutical Group

Symptoms and General Pathology

Substance Related Disorders

Syndrome

Diarrhea

Flushing

Malignant Carcinoid Syndrome

Serotonin Syndrome

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Pharmaceutical Solutions

Lanreotide

Hormones

Hormone Antagonists

Subjects received deep s.c. lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).

After completing the DB phase (or if they met criteria for early roll over \[ERO\]) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained \[whichever occurred first\]).

Subjects received deep s.c. placebo every 4 weeks (±3 days) for 16 weeks (DB phase).

After completing the DB phase (or if they met criteria for ERO) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained \[whichever occurred first\]).

deep s.c. injection, 120 mg, every 4 weeks (±3 days).

deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).

Placebo

Ipsen Medical Director

The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue medication to control symptoms in subjects with carcinoid syndrome.

This study consisted of a Screening period, conducted up to 4 months before randomisation, followed by three phases: a 16-week, double blind (DB), randomised, placebo-controlled phase; a 32-week initial open label (IOL) phase; and a long term open label extension (LTOLE) phase.

The DB phase evaluated lanreotide Autogel versus placebo in subjects with a history of carcinoid syndrome (flushing and/or diarrhoea). This was followed by a 32-week IOL phase in which all subjects received lanreotide Autogel 120 mg every 4 weeks. Subjects in countries where lanreotide Autogel had not been approved for the treatment of carcinoid syndrome, who were well-controlled at the end of the 32-week IOL phase and chose to continue to receive lanreotide Autogel, were given the option of participating in a LTOLE phase. The LTOLE phase of the study was planned to end at least 2 years after the last subject had completed his/her participation in the 32-week IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome had been obtained in the respective countries (whichever occurred first) or at any time the study was terminated by the Sponsor. The actual overall duration of the study was 6.5 years. During the LTOLE phase all subjects continued to be treated with lanreotide Autogel 120 mg every 4 weeks.

The study planned to enrol approximately 100 adult subjects worldwide. Screening continued until 115 subjects were enrolled in the study.

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.

Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).

Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Trial of Vandetanib Combined With 131I-mIBG to Treat Patients With Advanced Phaeochromocytoma and Paraganglioma	NCT01941849	Phaeochromocyto... Paraganglioma	Vandetanib 131I-mIBG	18 Years -	University College, London
Phase I Trial of Vandetanib Combined With 131I-mIBG to Treat Patients With Advanced Phaeochromocytoma and Paraganglioma	NCT01941849	Phaeochromocyto... Paraganglioma	Vandetanib 131I-mIBG	18 Years -	University College, London
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours	NCT01578239	Carcinoid Tumor... Neuroendocrine ...	Octreotide LAR 177Lu-DOTA0-Tyr...	18 Years -	Advanced Accelerator Applications
A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs	NCT05459844	Neuroendocrine ...	Lutetium[177Lu]... Octreotide LAR	18 Years -	Sinotau Pharmaceutical Group
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome	NCT00774930	Carcinoid Syndr...	Lanreotide Placebo	18 Years -	Ipsen
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour	NCT00842348	Non Functioning...	lanreotide (Aut...	18 Years -	Ipsen
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours	NCT01578239	Carcinoid Tumor... Neuroendocrine ...	Octreotide LAR 177Lu-DOTA0-Tyr...	18 Years -	Advanced Accelerator Applications
A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs	NCT05459844	Neuroendocrine ...	Lutetium[177Lu]... Octreotide LAR	18 Years -	Sinotau Pharmaceutical Group

Spots Global Cancer Trial Database for neuroendocrine tumour