| General information |
| Database: | DB00903 |
| Objective: | Octreotide and everolimus have demonstrated efficacy in neuroendocrine tumors. Pasireotide is a somatostatin analog with binding affinity to a broader range of somatostatin receptor subtypes than octreotide. they performed a phase I study to evaluate the safety and feasibility of combining pasireotide with everolimus in patients with advanced neuroendocrine tumors |
| Authors: | Chan JA, et al |
| Title: | Phase I study of pasireotide (SOM 230) and everolimus (RAD001) in advanced neuroendocrine tumors. |
| Journal: | Endocr Relat Cancer. |
| Year: | 2012 |
| PMID: | 22736724 |
| Trial Design |
| Clinical Trial Id: | NCT00804336 |
| Agent: | pasireotide (SOM 230) + everolimus (RAD001)
|
| Target: | pasireotide:Somatostatin receptor type 1, 2, 3, 5
|
| Cancer Type: | neuroendocrine tumour |
| Cancer Subtype: | advanced neuroendocrine tumours |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | pasireotide (SOM 230) + everolimus (RAD001) |
| Study Type: | Phase I study |
| Key Patients Feature: | All patients were required to be 18 years of age or older and have histologically documented, locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors of low grade or intermediate histologic grade. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with escalating doses of pasireotide (6001200 ¦Ìg s.c. b.i.d., followed by pasireotide LAR 4060 mg i.m. monthly) and everolimus (510 mg daily). |
| Primary End Point: | safety and feasibility |
| Secondary End Point: | NA |
| Patients Number: | 21 |
| Trial Results |
| DLT_MTD: | Doselimiting toxicities consisting of grade 3 rash and grade 3 diarrhea were observed. Ttheylve patients were safely treated at the maximum protocoldefined dose level of pasireotide LAR 60 mg i.m. monthly and everolimus 10 mg daily. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The proportion of patients on study who were progression free at 6 months was 76%, and the proportion progression free at 12 months was 65%. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Hyperglycemia was common; other observed toxicities were consistent with the known toxicities of either agent alone. |
| Conclusions: | pasireotide LAR 60 mg i.m. monthly in combination with everolimus 10 mg daily is feasible and associated with preliminary evidence of antitumor activity in patients with advanced neuroendocrine tumors. Further studies evaluating this combination are warranted. |