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

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ClinicalTrials.gov Identifier: NCT02705313
Recruitment Status : Approved for marketing
First Posted : March 10, 2016
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Advanced Accelerator Applications

Brief 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 access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Drug: 177Lu-DOTA0-Tyr3-Octreotate

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 Type : Expanded Access
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: 177Lu-DOTA0-Tyr3-Octreotate
    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.
    Other Name: Lutathera

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705313


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Locations
United States, Arizona
Banner M.D. Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
City of Hope (City of Hope Medical Center, City of Hope National Medical Center)
Duarte, California, United States, 91010
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
Kaiser Permanente, Santa Clara Homestead
Santa Clara, California, United States, 95051
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Cancer Treatment Center of America - Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Illinois
Northwestern Medicine
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
The University of Iowa Hospitals & Clinics (UIHC) including the Carver College of Medicine
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ochsner Medical Center
Kenner, Louisiana, United States, 70065
United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
CHI Health West Omaha Imaging Center
Omaha, Nebraska, United States, 68130
United States, New York
Montefiore Einstein Center for Cancer Care
Bronx, New York, United States, 10467
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Lenox Hill Hospital
New York, New York, United States, 10075
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University James Cancer Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh, Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Bon Secours Medical Group/ Saint Francis Hospital Cancer Center
Greenville, South Carolina, United States, 29697
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Utah
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24014
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
University of Washington, Department of Radiology, Division of Nuclear Medicine
Seattle, Washington, United States, 98185
Sponsors and Collaborators
Advanced Accelerator Applications

Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT02705313     History of Changes
Other Study ID Numbers: AAA-177Lu-03
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by Advanced Accelerator Applications:
neuroendocrine tumors
177Lu-DOTA0-Tyr3-Octreotate
PRRT

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue