Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
| Group | Value (Participants) |
|---|---|
| Lanreotide/Y-90 Microspheres | 6 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Closed due to slow accrual
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
NCT0285906428 Jul 2017 to 10 Jun 2022
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA approval to treat patients with metastatic NETs. The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.
Experimental
Lanreotide/Y-90 microspheres
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy. Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Outcomes the sponsor listed as primary.
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Time frame · From the day of the first dose to 30 days after the last dose of study medication, up to 52 months
Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Overall Response Rate
Time frame · At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
Percentage of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Disease Control Rate
Time frame · At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months.
Percentage of patients with CR, PR or stable disease (SD) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Stable Disease: Meeting neither criteria for PR or Progression (PD= greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions). Disease Control Rate (DCR) = CR + PR + SD.
Progression Free Survival
Time frame · At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Per RECIST V1.1 criteria, progression is defined as a greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.
Overall Survival
Time frame · At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months
The time from Day 1 of study drug administration until death from any cause.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Lanreotide/Y-90 Microspheres | 6 |
| Group | Value (percentage of participants) |
|---|---|
| Lanreotide/Y-90 Microspheres | 16.7 |
| Group | Value (percentage of participants) |
|---|---|
| Lanreotide/Y-90 Microspheres | 100 |
| Group | Value (months) |
|---|---|
| Lanreotide/Y-90 Microspheres | 11 |
| Group | Value (months) |
|---|---|
| Lanreotide/Y-90 Microspheres | 11.5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lanreotide/Y-90 MicrospheresLanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy. Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist. Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs. Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery. | 2 / 6 | 2 / 6 | 6 / 6 |
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