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

Expanded access is currently available for this treatment.
Verified July 2017 by Advanced Accelerator Applications
Sponsor:
Information provided by (Responsible Party):
Advanced Accelerator Applications
ClinicalTrials.gov Identifier:
NCT02705313
First received: March 7, 2016
Last updated: July 7, 2017
Last verified: July 2017
  Purpose
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). Considering that Phase III NETTER-1 clinical trial recruitment has been completed, this expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

Condition Intervention
Midgut Carcinoid Tumor Drug: 177Lu-DOTA0-Tyr3-Octreotate

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Midgut Carcinoid Tumors, Progressive Under Somatostatin Analogue Therapy

Resource links provided by NLM:


Further study details as provided by Advanced Accelerator Applications:

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
  Eligibility

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

Inclusion Criteria:

  • Presence of metastasized or locally advanced, inoperable (curative intent) at enrollment time, midgut carcinoid 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02705313

Contacts
Contact: Advanced Accelerator Applications Lutathera.EAP@adacap.com

  Show 23 Study Locations
Sponsors and Collaborators
Advanced Accelerator Applications
  More Information

Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT02705313     History of Changes
Other Study ID Numbers: AAA-177Lu-03
Study First Received: March 7, 2016
Last Updated: July 7, 2017

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

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017