Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-01 @ 10:38 AM
Study NCT ID:
NCT04316169
Status:
WITHDRAWN
Last Update Posted:
2022-12-23
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Hydroxychloroquine (HCQ) in Combination With Abemaciclib and Endocrine Therapy in HR+/Her 2- Advanced Breast Cancer After a Lead in Dose Escalation Cohort of HCQ and Abemaciclib in Advanced Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding and PI leaving institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis is that abemaciclib synergizes with autophagy inhibitor hydroxychloroquine (HCQ/ Plaquenil), inducing apoptosis leading to tumor regression.
Detailed Description:
Part 1: 3+3 dose escalation of HCQ combined with abemaciclib in advanced solid tumors.
Part 2: HCQ at top-dose level from part one is combined with abemaciclib and endocrine therapy in HR+/Her 2- advanced breast cancer (ABC) and divided into two cohorts based on prior exposure to endocrine therapy.
Primary Objective
1. Dose-escalation cohort: To determine safety and tolerability of HCQ combined with abemaciclib.
2. Dose-expansion cohort: To determine safety and tolerability of HCQ combined with abemaciclib and endocrine therapy in HR+/Her2- ABC.
Secondary Objectives
1. To assess the clinical efficacy of HCQ in combination with abemaciclib and hormone blockade in the dose- expansion cohort of advanced ER- positive breast cancer participants.
2. To assess the clinical efficacy of HCQ in combination with abemaciclib in the dose- escalation cohort
Part 2: HCQ at top-dose level from part one is combined with abemaciclib and endocrine therapy in HR+/Her 2- advanced breast cancer (ABC) and divided into two cohorts based on prior exposure to endocrine therapy.
Primary Objective
1. Dose-escalation cohort: To determine safety and tolerability of HCQ combined with abemaciclib.
2. Dose-expansion cohort: To determine safety and tolerability of HCQ combined with abemaciclib and endocrine therapy in HR+/Her2- ABC.
Secondary Objectives
1. To assess the clinical efficacy of HCQ in combination with abemaciclib and hormone blockade in the dose- expansion cohort of advanced ER- positive breast cancer participants.
2. To assess the clinical efficacy of HCQ in combination with abemaciclib in the dose- escalation cohort
Study Oversight
Has Oversight DMC:
True
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?: