Neuroendocrine TumorsNCT02705313
EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
A study testing 177Lu-DOTA0-Tyr3-Octreotate in people with Neuroendocrine Tumors, run by Advanced Accelerator Applications at 41 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-DOTA0-Tyr3-Octreotate
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 41 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Presence of metastasized or locally advanced neuroendocrine tumor, inoperable (curative intent) at enrollment time, and regardless of the origin of the tumor.
- Ki67 index ≤ 20%
- Patients progressive under SSA (any dose) at the time of enrollment
- Target lesions over-expressing somatostatin receptors according to an appropriate imaging method (e.g. 111In-pentetreotide (Octreoscan) imaging or 68Ga-DOTA0-Tyr3-Octreotate (or 68Ga-edotreotide) imaging)
Who cannot join
- Either serum creatinine >150 μmol/L (>1.7 mg/dL), or creatinine clearance <50 mL/min calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as confirmatory exam).
- Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L (75x103/mm3).
- Total bilirubin >3 x ULN.
- Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
- Pregnancy or lactation.
- For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
Show all 17Show fewer
- Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to enrollment.
- Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to enrollment.
- Known brain metastases, unless these metastases have been treated and stabilized.
- Uncontrolled congestive heart failure (NYHA II, III, IV).
- Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
- Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 4 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless the tumor uptake on target lesions is at least as high as normal liver uptake.
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to the patient safety
- Prior external beam radiation therapy to more than 25% of the bone marrow.
- Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.
- Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.
- Patients who have not provided a signed informed consent form to accept this treatment.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University James Cancer Center
Columbus, Ohio, 43210
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope (City of Hope Medical Center, City of Hope National Medical Center)
Duarte, California, 91010
Duke University Hospital
Durham, North Carolina, 27710
Banner M.D. Anderson Cancer Center
Gilbert, Arizona, 85234
Bon Secours Medical Group/ Saint Francis Hospital Cancer Center
Greenville, South Carolina, 29697
The University of Iowa Hospitals & Clinics (UIHC) including the Carver College of Medicine
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
Kansas City Research Institute
Kansas City, Missouri, 64131
Ochsner Medical Center
Kenner, Louisiana, 70065
University of California, Los Angeles
Los Angeles, California, 90095
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Cancer Treatment Center of America - Southeastern Regional Medical Center
Newnan, Georgia, 30265
CHI Health West Omaha Imaging Center
Omaha, Nebraska, 68130
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Hospital
Phoenix, Arizona, 85054
University of Pittsburgh, Medical Center
Pittsburgh, Pennsylvania, 15213
Carilion Clinic
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California, San Francisco
San Francisco, California, 94143
Kaiser Permanente, Santa Clara Homestead
Santa Clara, California, 95051
Virginia Mason Medical Center
Seattle, Washington, 98101
University of Washington, Department of Radiology, Division of Nuclear Medicine
Seattle, Washington, 98185
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Stony Brook Cancer Center
Stony Brook, New York, 11794
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10467
About this study
Official title: 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 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.
Read the detailed description
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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 177Lu-DOTA0-Tyr3-Octreotate
- Keywords
- neuroendocrine tumors, 177Lu-DOTA0-Tyr3-Octreotate, PRRT
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTA0-Tyr3-OctreotateDrug
Also called Lutathera
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705313
- Sponsor's protocol ID
- AAA-177Lu-03
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2016
- Last updated
- 9 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02705313
- Acronym / sponsor ID
- AAA-177Lu-03
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumors, 177Lu-DOTA0-Tyr3-Octreotate, PRRT
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- First posted
- 10 Mar 2016 (estimated)
- 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.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of metastasized or locally advanced neuroendocrine tumor, inoperable (curative intent) at enrollment time, and regardless of the origin of the tumor.
- Ki67 index ≤ 20%
- Patients progressive under SSA (any dose) at the time of enrollment
- Target lesions over-expressing somatostatin receptors according to an appropriate imaging method (e.g. 111In-pentetreotide (Octreoscan) imaging or 68Ga-DOTA0-Tyr3-Octreotate (or 68Ga-edotreotide) imaging)
Key exclusion criteria (17 listed)
- Either serum creatinine >150 μmol/L (>1.7 mg/dL), or creatinine clearance <50 mL/min calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as confirmatory exam).
- Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L (75x103/mm3).
- Total bilirubin >3 x ULN.
- Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
- Pregnancy or lactation.
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 |
|---|---|---|
| 177Lu-DOTA0-Tyr3-OctreotateAlso: LutatheraThe 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
Related trials for Neuroendocrine Tumors
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Active, not recruitingPhase 2
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 177Lu-DOTA0-Tyr3-Octreotate in people with Neuroendocrine Tumors, run by Advanced Accelerator Applications at 41 sites in United States.
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 4 inclusion and 17 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 9 Apr 2018.