Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02983071
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-15
First Post:
2016-11-29
Brief Title:
G1T38 a CDK 46 Inhibitor in Combination With Fulvestrant in Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer
Sponsor:
G1 Therapeutics Inc
Organization:
G1 Therapeutics Inc
Study Overview
Official Title:
Phase 12 Safety Pharmacokinetic and Antitumor Activity Study of G1T38 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer After Endocrine Failure
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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 is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive HER2-negative metastatic breast cancer
The study is an open-label design consists of 2 parts dose-finding portion Part 1 and expansion portion Part 2 Both parts include 3 study phases Screening Phase Treatment Phase and Survival Follow-up Phase The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit Approximately 102 patients will be enrolled in the study
The study is an open-label design consists of 2 parts dose-finding portion Part 1 and expansion portion Part 2 Both parts include 3 study phases Screening Phase Treatment Phase and Survival Follow-up Phase The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit Approximately 102 patients will be enrolled in the study
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001485-29 | EUDRACT_NUMBER | None | None |