Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554730
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Merck Belzutifan PAS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non Interventional Post-Authorization Study of Belzutifan in Adult Patients With Von Hippel Lindau Disease-associated Renal Cell Carcinoma Pancreatic Neuroendocrine Tumor andor Central Nervous System Hemangioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice
Detailed Description:
Primary Objective
Among new users ofbelzutifan with VHL disease-associated RCC to describe the proportion of patients who undergo at least one renal tumor reductive surgery eg nephrectomy or locally directed therapy eg radiofrequency ablation
Among new users ofbelzutifan with VHL disease-associated CNS hemangioblastoma to describe the proportion of patients who undergo at least one CNS tumor reductive surgery eg craniectomy or locally directed therapy eg radiation therapy
Secondary Objectives
Among all new users of belzutifan ยน to describe
- Proportion of patients with treatment emergent SAEs including the nature of these events
Treatment patterns including the
Duration of therapy
Proportion of patients who discontinued treatment time to treatment discontinuation and summary of reasons for discontinuation
Proportion of patients who interrupted treatment time to treatment interruption duration of treatment interruption and summary of reasons for treatment interruption
Proportion of patients with dose reductions and reason for dose reduction
Among new users of belzutifan with VHL disease-associated RCC and separately VHL disease-associated CNS hemangioblastoma to describe
Proportion of patients who develop metastatic disease for RCC only
Proportion of patients with occurrence of new VHL disease-associated tumor or tumor type
Among new users ofbelzutifan with VHL disease-associated RCC to describe the proportion of patients who undergo at least one renal tumor reductive surgery eg nephrectomy or locally directed therapy eg radiofrequency ablation
Among new users ofbelzutifan with VHL disease-associated CNS hemangioblastoma to describe the proportion of patients who undergo at least one CNS tumor reductive surgery eg craniectomy or locally directed therapy eg radiation therapy
Secondary Objectives
Among all new users of belzutifan ยน to describe
- Proportion of patients with treatment emergent SAEs including the nature of these events
Treatment patterns including the
Duration of therapy
Proportion of patients who discontinued treatment time to treatment discontinuation and summary of reasons for discontinuation
Proportion of patients who interrupted treatment time to treatment interruption duration of treatment interruption and summary of reasons for treatment interruption
Proportion of patients with dose reductions and reason for dose reduction
Among new users of belzutifan with VHL disease-associated RCC and separately VHL disease-associated CNS hemangioblastoma to describe
Proportion of patients who develop metastatic disease for RCC only
Proportion of patients with occurrence of new VHL disease-associated tumor or tumor type
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None