Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01646684
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2012-07-18
Brief Title:
Phase 1 Study to Evaluate Safety Tolerability Pharmacokinetics and Preliminary Efficacy of Pasireotide LAR in Patients With Castration Resistant Prostate Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase 1 Study to Evaluate Safety and Preliminary Efficacy of Pasireotide LAR in Castration Resistant Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After failure of initial ADT addition of an anti-androgen is established to treat castration resistant prostate cancer CRPC Substitution of the first anti-androgen and anti-androgen withdrawal results in treatment responses in 25-40 of patients for 4-6 months A more effective second line treatment after failure of first ADT could prolong the time until the state of symptomatic HRPC which is currently treated with docetaxel and accompanied by significant side effects Since the importance of the IGF-signaling in PC is not only indicated by preclinical results but also by clinical efficacy of somatostatin analogs further clinical research with the new somatostatin analog pasireotide is warranted
This study is designed to define the maximum tolerated dose MTD of pasireotide LAR in patients with castration resistant prostate cancer CRPC It also aims for a preliminary efficacy evaluation of pasireotide within the dose expansion part at the MTD Preliminary efficacy will be assessed by evaluation of different measures of prostate cancer eg changes in PSA disease control rate RECIST 11 symptoms and changes of biomarkers linked to the mode of action of pasireotide LAR The study will also explore characteristics of patients who might benefit most from this treatment approach
This study is designed to define the maximum tolerated dose MTD of pasireotide LAR in patients with castration resistant prostate cancer CRPC It also aims for a preliminary efficacy evaluation of pasireotide within the dose expansion part at the MTD Preliminary efficacy will be assessed by evaluation of different measures of prostate cancer eg changes in PSA disease control rate RECIST 11 symptoms and changes of biomarkers linked to the mode of action of pasireotide LAR The study will also explore characteristics of patients who might benefit most from this treatment approach
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-024399-25 | EUDRACT_NUMBER | None | None |