Clinical trial · Interventional
Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
NCT01364415CI-TRIAL-00049041completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pasireotide LAR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pasireotide LAR
- interventionNames
- Drug: Pasireotide LAR
Primary outcomes (1)
- measure
- Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
- timeFrame
- Sequentiona 56 day cohorts until the MTD is determined
- description
- Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
Secondary outcomes (4)
- measure
- assess the safety and tolerability of pasireotide LAR
- timeFrame
- minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma * unresectable metastatic NET tumor with measurable disease * life expectancy ≥ 12 weeks Exclusion Criteria: * Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease * patients with known hypersensitivity to somatostatin analogs * patients with symptomatic cholelithiasis in the past 2 months * patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix * patients with known history of hepatitis C or chronic active hepatitis B * patients with diagnosis of HIV. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDYao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Resendiz K, Hu K, Ravichandran S, Strosberg JR, Wolin EM. Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors. Onco Targets Ther. 2017 Jun 27;10:3177-3186. doi: 10.2147/OTT.S128547. eCollection 2017. PMID 28721067