Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04274933
Status:
TERMINATED
Last Update Posted:
2020-10-29
First Post:
2020-02-17
Brief Title:
A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK46 Inhibitor Therapy
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1b Study of Venetoclax and Capecitabine In Subjects With Hormone Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Experienced Disease Progression During or After CDK46 Inhibitor Therapy
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endocrine therapy is the initial treatment for most hormone receptor positive HR human epidermal growth factor receptor 2 negative HER2- breast cancers This study will evaluate the use of venetoclax in combination with capecitabine in adult participants with HR HER2- metastatic breast cancer MBC who had disease progression following treatment that included a cyclin-dependent kinase 46 CDK46 inhibitor
Venetoclax is an investigational drug being developed for the treatment of breast cancer This study is open-label meaning both the participants and study doctors will know what treatment is being given The study includes two phases dose escalation and dose expansion In dose escalation participants will receive various doses of venetoclax in combination with capecitabine In dose expansion participants will receive the recommended dose of venetoclax determined during dose escalation in combination with capecitabine Adult participants with locally advanced or MBC that is not amenable to curative therapy will be enrolled Around 42 participants will be enrolled at approximately 20 sites worldwide
Venetoclax and capecitabine will be administered on a 21-day cycle During dose escalation participants will take various doses of venetoclax as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks During dose expansion participants will take venetoclax at the dose identified during dose escalation as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks
There may be a higher burden for participants in this trial compared to standard of care Participants will attend weekly visits during the course of the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests and evaluating for side effects
Venetoclax is an investigational drug being developed for the treatment of breast cancer This study is open-label meaning both the participants and study doctors will know what treatment is being given The study includes two phases dose escalation and dose expansion In dose escalation participants will receive various doses of venetoclax in combination with capecitabine In dose expansion participants will receive the recommended dose of venetoclax determined during dose escalation in combination with capecitabine Adult participants with locally advanced or MBC that is not amenable to curative therapy will be enrolled Around 42 participants will be enrolled at approximately 20 sites worldwide
Venetoclax and capecitabine will be administered on a 21-day cycle During dose escalation participants will take various doses of venetoclax as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks During dose expansion participants will take venetoclax at the dose identified during dose escalation as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks
There may be a higher burden for participants in this trial compared to standard of care Participants will attend weekly visits during the course of the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests and evaluating for side effects
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003452-36 | EUDRACT_NUMBER | None | None |