Entry Detail
| General information | |
| Database: | DB00669 |
| Objective: | they investigated the antitumour activity and safety profile of pazopaniba multitarget drug with antiangiogenic activity in patients with metastatic GEP NETs. |
| Authors: | Ahn HK, et al |
| Title: | Phase II study of pazopanib monotherapy in metastatic gastroenteropancreatic neuroendocrine tumours. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 23989950 |
| Trial Design | |
| Clinical Trial Id: | NCT01099540 |
| Agent: | pazopanib |
| Target: | Plateletderived growth factor receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | neuroendocrine tumour |
| Cancer Subtype: | advanced gastroenteropancreaticneuroendocrine tumours |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a nonrandomised, openlabeled, singlecenterphase II study |
| Key Patients Feature: | Eligibility criterion included a histologically confirmeddiagnosis of advanced (metastatic) GEP NET, which is notamenable to locoregional therapies including transarterial embolisation or radiofrequency ablation. Histological grade wascategorised as follows: carcinoid tumour or welldifferentiatedNET was classified as G1 tumour; atypical carcinoid or welldifferentiated neuroendocrine carcinoma was classified as G2tumour and poorly differentiated neuroendocrine carcinoma wasclassified as G3 tumour (Klimstra et al, 2010). In patients with G3NET, one previous cytotoxic chemotherapy regimen was requiredto enter the trial. Tumours originating from GI tract or unknownprimary site, or nonfunctioning pancreatic islet cell tumour wasincluded |
| Biomarker: | Correlative biomarker analyses |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Pazopanib was orally administered at a dose of 800 mg daily continuously with a 28day cycle. An independent review of objective response was planned. |
| Primary End Point: | an objective response rate |
| Secondary End Point: | progression free survival (PFS), overall survival (OS) and safety. |
| Patients Number: | 37 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Thisphase II study demonstrated an objective response rate of 18.9% (7 of the 37, 95% CI 8.035.2) and a disease control rate (CR+confirmed PR+stable disease) of 75.7% (28 of the 37, 95% CI, 58.888.2) in metastatic GEP NETs. The independent review demonstrated a higher overall response rate of 24.3% (95% CI, 11.841.2%) with nine confirmed PRs. |
| Disease Control Rate: | 75.7% (28 of the 37, 95% CI, 58.8-88.2) in metastatic GEP NETs. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.1 months (95% CI 4.9-13.3 months) |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | The most common grades 3 and 4 AEs were proteinuria (11%), neutropaenia (8%), hypertension (5%), diarrhoea (5%), anorexia (5%), abdominal pain (5%) and AST/ALT elevation (5%). There was no treatmentrelated mortality. |
| Conclusions: | Pazopanib showed a comparable efficacy to other targeted agents not only in pancreatic NETs but also in NETs originating from gastrointestinal (GI) tract. |