Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Somatostatin

Lutetium Lu 177 dotatate

Radiopharmaceuticals

177Lu-Octreotate (LuTate) P-PRRT will be administered as follows:

* Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles.
* The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s).
* Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles.
* Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s).

* The induction course will consist in 4 cycles at 8-10 weeks intervals.
* Concomitant amino acids will be administered for renal protection.
* Intra-arterial LuTate administration will be allowed in suitable cases.
* Dosimetry will be based on quantitative SPECT/CT imaging.
* In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

177Lu-Octreotate

Jean-Mathieu Beauregard, MD,MSc,FRCPC

Geneviève Filion

François-Alexandre Buteau, MD, FRCPC

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.

The purpose of this study is to:

* Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT;
* Assess the overall, the disease-specific, and the progression-free survival following P-PRRT;
* Correlate therapeutic response and survival with tumor absorbed radiation dose;
* Evaluate the acute, subacute and chronic adverse events following P-PRRT;
* Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk;
* Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research).

This study also has a compassionate purpose, which is to provide access to PRRT to patients.

A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor.

The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants.

This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.

The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

Personalized PRRT of Neuroendocrine Tumors

Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study

Correlation between cumulative absorbed radiation dose to tumor lesions and 3-month objective response rate, as defined above

Correlation between cumulative absorbed radiation dose to tumor lesions and survival endpoints above (PFS and OS)

Correlation between cumulative absorbed radiation dose to kidney and variations in glomerular filtration rate from baseline, reported annually for at least 5 years after first cycle or until study completion.

Correlation between cumulative absorbed radiation dose to bone marrow and chronic variations of blood counts from baseline, reported annually for at least 5 years after first cycle or until study completion.

Correlation between per-cycle absorbed radiation dose to bone marrow and subacute variations (nadir values between 2 and 6 weeks) of blood counts from baseline, for each cycle.

Primary efficacy endpoint is the objective response rate on contrast-enhanced CT (or MRI) by RECIST criteria (and secondarily by South Western Oncology Group (SWOG) criteria) at 3 months after the 4th induction cycle of P-PRRT, in comparison to pre-treatment scan (within 3 months before commencing P-PRRT).

Progression of disease is defined as the time from first cycle to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria.

Proportion of participants with improved, stable or worsened NET-related symptoms (frequency and severity), based on participant interviews at baseline and 3 months after completion of induction course.

Proportion of participants with improved, stable or worsened quality of life score by EORTC quality of life questionnaires QLQ-C30 and QLQ-GI.NET21, administered at baseline and 3 months after induction course.

Proportion of participants with improved (decreased by 25% or more), stable or worsened (increased by 25% or more) Chromogranin-A serum levels performed at baseline and 3 months after induction course.

CHU de Quebec-Universite Laval

The treatment regimen consists of 4 administrations of 7.4 GBq (200 mCi) at the date and time of infusion. The recommended interval between two infusions is 8 weeks, which could be extended up to 16 weeks in case of dose modifying toxicity.

177Lu-DOTA0-Tyr3-Octreotate

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

Advanced Accelerator Applications activated in 2012 a multicenter, stratified, open, randomized, comparator-controlled, parallel-group Phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to 60 mg Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors (NETTER-1 trial, EudraCT number 2011-005049-11, IND number 77219).

Clinical studies, including NETTER-1 for which the primary analysis has been conducted, showed clinical evidence of safety and effectiveness to support the expanded access use without any unreasonable potential risks for the patients in the context of the disease to be treated.

In July 2016, the first patient was treated under an Expanded Access Program (EAP) for inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors.

Compassionate use programs in Europe include pulmonary NETs. In the US, there were many centers with patients with NETs who did not meet the inclusion criteria for the original EAP. In May 2017, Advanced Accelerator Applications inquired with the FDA if amending the inclusion criteria of the original protocol to include all NETs would be permissible.

In June 2017, Advanced Accelerator Applications was able to submit a revision to the original Expanded Access Program's protocol for 177Lu-DOTA0-Tyr3-Octreotate to include neuroendocrine tumors arising from sites other than midgut.

The locations listed below that are participating in the EAP may have received IRB approval for either the original protocol or the new protocol or both. Please, inquire with the Facility Contact as to which protocol is active at their site.

EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx

Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Neuroendocrine Tumors, Progressive Under Somatostatin Analogue Therapy

Advanced Accelerator Applications

Symptoms and General Pathology

Neoplasm Metastasis

Hematinics

Antineoplastic Agents

Gastrointestinal Agents

Amino Acids

Liver Extracts

Octreotide

Edotreotide

Antineoplastic Agents, Hormonal

Phenylalanine

Subject will be administered 2.96 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 3.33 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 3.7 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 4.17 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 4.44 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 5.18 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Intra-arterial infusion to the liver of \[90\]Y-DOTATOC. The administered dose is determined by cohort and is dependent upon the results of the previous cohort.

[90]Y-DOTATOC

M. S O'Dorisio, MD, PhD

Sandeep Laroia, MD

This is a safety study to determine the phase 1 starting dose of \[90\]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

\[90\]Yttrium-DOTATOC is a radioactive drug used for peptide receptor radionuclide therapy (PRRT). In other studies, 90Y-DOTATOC has been administered through a vein (IV) to target somatostatin receptor positive tumor tissue. The DOTATOC identifies the tumor through the somatostatin receptor and links to it, attaching the radioactive molecule 90Yttrium to the malignant cell.

This study expands the initial work to examine if administering the drug 90Y-DOTATOC directly to the liver is safe for patients with neuroendocrine tumors whose disease has spread to their tumor. We don't know how of the 90Y-DOTATOC is safe to administer. We want to learn what the maximum safe dose is and what the side effects are related to that dose.

This is a sequential early phase 1 study using Storer's phase 1 design B.

Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases

Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases

Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.

Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes

Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count

Evaluate bone marrow toxicity using using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for absolute neutrophil count

Determine the distribution of 90Y-DOTATOC using post-treatment imaging

National Institutes of Health (NIH)

Holden Comprehensive Cancer Center

National Cancer Institute (NCI)

Sandeep Laroia

Associate Professor

Digestive System Diseases

Gland and Hormone Related Diseases

Intestinal Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Gastro-enteropancreatic Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Pancreatic Cancer

Stomach Cancer

Anti-Infective Agents

Everolimus

Sunitinib

Lanreotide

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Part 1 is an uncontrolled dose de-escalation study to confirm the safety and determine the RP3D of RYZ101 based on Bayesian optimal interval design. Eligible participants will be enrolled in cohorts of 6 to receive RYZ101 up to 4 infusions every 8 weeks. If the initial dose level is not tolerated, the dose will be de-escalated; up to 3 dose levels will be assessed.

Actinium 225 radiolabeled somatostatin analog (SSA) for injection

Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.

RYZ101

Everolimus 10 mg

Sunitinib 37.5 MG

High-dose octreotide LAR 60 mg Q4W by i.m. injection

Octreotide LAR 60 MG Injection

High dose frequency lanreotide 120 mg Q2W by deep s.c. injection

Lanreotide 120Mg Sa Susp Inj Syringe

Denis Ferreira, MD

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy

Incidence and severity of AEs by NCI CTCAE v5, including SAEs, laboratory changes, ECG changes, and other safety findings

Relationship between biomarkers, including but not limited to CgA in the serum and (5-HIAA) in the urine, with AEs of special interest and/or efficacy endpoints (e.g., PFS, OS, BOR, DoR)

Measured by continuous ECG recording using a 12-lead Holter monitoring device

Incidence of DLTs during the first 56 days of study treatment will be assessed.

PFS will be defined as the time from the date of randomization until the date of progression (as determined by BICR from tumor assessments using RECIST v1.1) or death due to any cause, whichever occurs earlier.

Calculated mean TIAC (hours) and absorbed radiation dose coefficients (mGy/MBq) to critical organs (e.g., the kidneys and bone marrow) and tumors after the 1st and 4th RYZ101 infusions will be assessed

OS will be defined as the time from the date of randomization until the date of death due to any cause.

ORR, as determined by BICR according to RECIST v1.1.

ORR, as assessed by the Investigator according to RECIST v1.1

Assessed by BICR and by the Investigator according to RECIST v1.1

Only for subjects with a RECIST v.1.1 response, assessed by BICR and by the Investigator according to RECIST v1.1

RayzeBio, Inc.

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.

Lutetium\[177Lu\] Oxodotreotide InjectionFour 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

Ming Lu, professor

Zhi Yang, professor

his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium\[177Lu\] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, 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 assigned to treatment with Lutetium\[177Lu\] Oxodotreotide Injection. Objective tumor assessment in both groups was performed every 12+/-1 weeks from the first treatment date according to RECIST 1.1 Criteria until progression.

Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Inoperable Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.

PFS is defined as the time from the date of first dose to the first documented disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized PRRT of Neuroendocrine Tumors	NCT02754297	Neuroendocrine ... Carcinoid Tumor Carcinoma, Neur...	177Lu-Octreotat...	18 Years -	CHU de Quebec-Universite Laval
EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx	NCT02705313	Neuroendocrine ...	177Lu-DOTA0-Tyr...	18 Years -	Advanced Accelerator Applications
Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases	NCT03724409	Neuroendocrine ...	[90]Y-DOTATOC	18 Years -	University of Iowa
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy	NCT05477576	GEP-NET Gastroenteropan... Gastroenteropan... Neuroendocrine ... Carcinoid Carcinoid Tumor Pancreatic NET	RYZ101 Everolimus 10 m... Sunitinib 37.5 ... Octreotide LAR ... Lanreotide 120M...	18 Years -	RayzeBio, Inc.
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors	NCT05894486	Neuroendocrine ...	Lutetium[177Lu]...	18 Years - 75 Years	Peking University
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors	NCT05894486	Neuroendocrine ...	Lutetium[177Lu]...	18 Years - 75 Years	Peking University
EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx	NCT02705313	Neuroendocrine ...	177Lu-DOTA0-Tyr...	18 Years -	Advanced Accelerator Applications

Spots Global Cancer Trial Database for prrt

Every month we try and update this database with for prrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prrt

Every month we try and update this database with for prrt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.