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Anti-cancer Drug

Tolinapant + Eribulin for Breast Cancer

Phase 1

Recruiting

Led By Kristen Kelley

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

* Patients must have confirmed locally advanced and unresectable or metastatic disease by either imaging or tissue diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at start of treatment to death, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of combining ASTX660 (tolinapant) with eribulin mesylate (eribulin) to treat patients with triple negative breast cancer that

Who is the study for?

This trial is for adults with advanced triple negative breast cancer that can't be surgically removed or has spread. Participants must have tried at least two systemic treatments, have measurable disease by certain criteria, and meet specific blood cell count requirements.

What is being tested?

The trial tests the safety and effectiveness of ASTX660 (tolinapant) combined with usual chemotherapy drug eribulin in patients with unresectable or metastatic triple negative breast cancer. It aims to find the best dose and see if this combination helps stop tumor growth.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as infections, fatigue, nausea, hair loss from chemotherapy, and possible unknown effects from the investigational drug ASTX660.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities, but may need help.

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My cancer is advanced and cannot be removed by surgery.

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My breast cancer is triple negative or has low hormone receptors and is HER2 negative.

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I have undergone at least 2 treatments for my cancer that has spread.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at start of treatment to death, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at start of treatment to death, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at start of treatment to death, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities (DLT)

Incidence of adverse events (AEs)

Maximum tolerated dose (MTD)

Secondary study objectives

Area under the curve (AUC) of ASTX660 (tolinapant) and eribulin

Change in cleaved caspase 3 levels

Clearance of ASTX660 (tolinapant) and eribulin

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tolinapant, eribulin)Experimental Treatment7 Interventions

Patients receive tolinapant PO QD on days 1-7 and 15-21 and eribulin 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 CT or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Computed Tomography

2017

Completed Phase 2

~2790