Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666129
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2020-12-07
Brief Title:
Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Sumitomo Pharma Switzerland GmbH
Organization:
Sumitomo Pharma Switzerland GmbH
Study Overview
Official Title:
A Phase 1 Three-Part Open-Label Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination with Abiraterone Acetate Plus a Corticosteroid Apalutamide or Docetaxel with or Without Prednisone in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy ADT for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer either metastatic castration-sensitive prostate cancer mCSPC or non-metastatic or metastatic castration-resistant prostate cancer nmCRPC or mCRPC
Detailed Description:
This is a three-part open-label parallel-cohort study to assess the safety and tolerability of relugolix as the ADT component in combination treatment with abiraterone acetate plus a corticosteroid in patients with mCSPC or mCRPC Part 1 apalutamide in patients with mCSPC or nmCRPC Part 2 or docetaxel with or without prednisone in patients with mCSPC or mCRPC Part 3
The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments Parts 1 2 or 3 All participants are required to be currently or previously treated with a GnRH receptor antagonist analog leuprolide acetate or triptorelin or a GnRH receptor antagonist degarelix or relugolix in combination with either abiraterone plus prednisone Part 1 apalutamide Part 2 or docetaxel Part 3 The study consists of a 12-week primary study treatment period in which safety and tolerability including assessment of vital sign measurements ECGs clinical laboratory tests and reporting of adverse events every 2 to 4 weeks followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported The total treatment duration is 52 weeks
The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments Parts 1 2 or 3 All participants are required to be currently or previously treated with a GnRH receptor antagonist analog leuprolide acetate or triptorelin or a GnRH receptor antagonist degarelix or relugolix in combination with either abiraterone plus prednisone Part 1 apalutamide Part 2 or docetaxel Part 3 The study consists of a 12-week primary study treatment period in which safety and tolerability including assessment of vital sign measurements ECGs clinical laboratory tests and reporting of adverse events every 2 to 4 weeks followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported The total treatment duration is 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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