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Tests treatment safety and results for Somatostatin Receptor Positive (SSTR+)
Official title Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
ClinicalTrials.gov ID: NCT06784752
What this study is testing
What is Octreotide LAR?
Octreotide LAR is an investigational medicine, being studied as a potential treatment for somatostatin receptor positive (sstr+).
Also referred to as SOM230.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the current study is to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 100
You may be able to join if
- Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67...
- Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high...
- Primary tumor or a metastatic lesion \> 4 cm
- More than one tumor or metastatic lesions measuring \> 2 cm
- Elevated alkaline phosphatase \> 2.5 X upper limit of normal (ULN)
You likely can't join if
- Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
- Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If...
- Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible. In addition, any participant...
- Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.
- Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET.
- Any major surgery within 12 weeks prior to randomization in the study.
See the full eligibility criteria
- Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 \<10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed...
- Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:
- Primary tumor or a metastatic lesion \> 4 cm
- More than one tumor or metastatic lesions measuring \> 2 cm
- Elevated alkaline phosphatase \> 2.5 X upper limit of normal (ULN)
- Presence of bone metastasis
- Presence of peritoneal metastasis
- Symptoms due to tumor volume such as pain, fatigue, weight loss, anorexia etc.
- Symptoms due to hormone excess requiring active management
- Additionally, participants who, in the Investigator's opinion, have high disease burden due to their disease characteristics not specified above could also be considered eligible.
- Participants ≥ 12 years of age.
- RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake assessed within 3 months prior to randomization. Any of the RLI modalities as...
- [68Ga]Ga-DOTA-TOC PET/CT or PET/MRI
- [68Ga]Ga-DOTA-TATE PET/CT or PET/MRI
- [64Cu]Cu-DOTA-TATE PET/CT or PET/MRI
- Somatostatin receptor scintigraphy (SRS) (planar and/or SPECT/CT) with [111In]In-pentetreotide
- SRS (planar and/or SPECT/CT) with [99mTc]Tc-octreotide.
- Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:
- White blood cell (WBC) count ≥ 2 x 109/L
- Platelet count ≥ 75 x 109/L
- Hemoglobin (Hb) ≥ 8 g/dL
- Creatinine clearance \> 40 mL/min calculated by the Cockcroft Gault method
- Total bilirubin ≤ 3 x ULN
- Potassium within normal limits. Potassium level of up to 6.0 millimoles per liter (mmol/L) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using Cockcroft-Gault...
- ECOG performance status 0-1.
- Presence of at least 1 measurable site of disease.
- Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any time prior to randomization in the study.
- Any previous therapy with interferons, mTOR-inhibitors, chemotherapy or other systemic therapies except somatostatin analogues (SSAs) of GEP-NET. If as per Investigator's opinion a participant is candidate for such...
- Participant who received more than 4 cycles of prior SSAs (e.g., octreotide long-acting release) are not eligible. In addition, any participant receiving treatment with short-acting octreotide, which cannot be...
- Documented RECIST v1.1 progression during previous SSA treatments for the current GEP-NET at any time prior to randomization.
- Any previous radioembolization, chemoembolization and radiofrequency ablation for GEP-NET.
- Any major surgery within 12 weeks prior to randomization in the study.
- Known brain metastases.
- Participant with known intolerance to CT scans with intravenous (i.v.) contrast due to allergic reaction or renal insufficiency. If such a participant can be imaged with MRI, then the participant would not be excluded.
- Hypersensitivity to any somatostatin analogues, to the Investigational Medicinal Products (IMPs) active substance or to any of the excipients.
- Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the Investigator, could prevent adhering to radiation safety...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Denver, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Edgewood, Kentucky, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Winston-Salem, North Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
- Wytheville, Virginia, United States
- Tacoma, Washington, United States
- Edmonton, Alberta, Canada
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Fayetteville, Arkansas, United States; Denver, Colorado, United States; Hartford, Connecticut, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.