A Phase 4 interventional study of Octreotide and LAR Lanreotide in Neuroendocrine Tumors, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 4, Interventional, and Treatment
This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.
Exclusion Criteria:
Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
*Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study
Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Drug: Octreotide · Drug: LAR Lanreotide · Behavioral: Questionnaires
Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Drug: Octreotide · Drug: LAR Lanreotide · Behavioral: Questionnaires
Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.
Mean Pain Scores at 3 Months
Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.
Time frame: 3 months
| Milestone | Octreotide Then Lanreotide | Lanreotide Then Octreotide |
|---|---|---|
| Started | 26 | 25 |
| Completed | 22 | 22 |
| Not completed | 4 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Physician decision | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.
| scores on a scale | Octreotide Then Lanreotide | Lanreotide Then Octreotide |
|---|---|---|
| Octreotide, first intervention (3 months) | 2.4 (0 to 10) | — |
| Lanreotide, second intervention (6 months) | 2.4 (0 to 10) | — |
| Lanreotide, first intervention (3 months) | — | 1.9 (0 to 10) |
| Octreotide, second intervention (6 months) | — | 1.9 (0 to 10) |
Collected over Up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Octreotide | 13/51 (25.5%) | 13/51 (25.5%) | 0/51 (0%) |
| Lanreotide | 8/51 (15.7%) | 8/51 (15.7%) | 0/51 (0%) |
| Event | Octreotide | Lanreotide |
|---|---|---|
| Death NOSGeneral disorders | 13/51 | 8/51 |
| Age, Continuous(years) | Octreotide Then Lanreotide | Lanreotide Then Octreotide | Total |
|---|---|---|---|
| Mean | 63 (40 to 83) | 67 (47 to 87) | 65 (40 to 87) |
| Sex: Female, Male(Participants) | Octreotide Then Lanreotide | Lanreotide Then Octreotide | Total |
|---|---|---|---|
| Female | 11 | 15 | 26 |
| Male | 15 | 10 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Octreotide Then Lanreotide | Lanreotide Then Octreotide | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 23 | 21 | 44 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Octreotide Then Lanreotide | Lanreotide Then Octreotide | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 4 | 4 |
| White | 21 | 19 | 40 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Octreotide Then Lanreotide | Lanreotide Then Octreotide | Total |
|---|---|---|---|
| United States | 26 | 25 | 51 |
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Memorial Sloan Kettering Cancer Center