Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Testing the Addition of an Investigational Anti-Cancer Drug ASTX660 Tolinapant to a Usual Chemotherapy Treatment Eribulin for Treatment of Advanced Triple Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IIb Study of Eribulin in Combination With ASTX660 Tolinapant in Metastatic Triple Negative Breast Cancer TNBC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 phase IIb trial tests the safety side effects best dose and effectiveness of ASTX660 tolinapant in combination with eribulin mesylate eribulin in treating patients with triple negative breast cancer that cannot be removed by surgery unresectable or that has spread to nearby tissues or lymph nodes locally advanced or to other places in the body metastatic Tolinapant may stop the growth of tumor cells by blocking proteins such as XIAP and cIAP1 needed for tumor cell survival Chemotherapy drugs such as eribulin work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving tolinapant in combination with eribulin may be safe tolerable andor effective in treating patients with unresectable locally advanced or metastatic triple negative breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of ASTX660 tolinapant in combination with eribulin in patients with metastatic breast cancer
II Determine the maximum tolerated dose MTD of ASTX660 tolinapant in combination with eribulin
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II Determine the pharmacokinetic parameters of ASTX660 tolinapant and eribulin when used in combination
III Determine the pharmacodynamic parameters of antitumor activity of ASTX660 tolinapant and eribulin combination
EXPLORATORY OBJECTIVES
I Develop biomarkers predictive of response and resistance to ASTX660 tolinapant in combination with eribulin in metastatic triple negative breast cancer
II Investigate biomarkers and mechanisms of primary and secondary resistance to ASTX660 tolinapant in combination with eribulin in metastatic triple negative breast cancer
OUTLINE This is a dose-escalation study of tolinapant in combination with eribulin followed by a dose-expansion study
Patients receive tolinapant orally PO once daily QD on days 1-7 and 15-21 and eribulin intravenously IV over 2-5 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection tissue biopsy chest X-ray and computed tomography CT or magnetic resonance imaging MR during screening and on study
After completion of study treatment patients are followed for up to 3 months
I Determine the safety and tolerability of ASTX660 tolinapant in combination with eribulin in patients with metastatic breast cancer
II Determine the maximum tolerated dose MTD of ASTX660 tolinapant in combination with eribulin
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity II Determine the pharmacokinetic parameters of ASTX660 tolinapant and eribulin when used in combination
III Determine the pharmacodynamic parameters of antitumor activity of ASTX660 tolinapant and eribulin combination
EXPLORATORY OBJECTIVES
I Develop biomarkers predictive of response and resistance to ASTX660 tolinapant in combination with eribulin in metastatic triple negative breast cancer
II Investigate biomarkers and mechanisms of primary and secondary resistance to ASTX660 tolinapant in combination with eribulin in metastatic triple negative breast cancer
OUTLINE This is a dose-escalation study of tolinapant in combination with eribulin followed by a dose-expansion study
Patients receive tolinapant orally PO once daily QD on days 1-7 and 15-21 and eribulin intravenously IV over 2-5 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection tissue biopsy chest X-ray and computed tomography CT or magnetic resonance imaging MR during screening and on study
After completion of study treatment patients are followed for up to 3 months
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