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Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

NCT04134884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-03-22

No results posted yet for this study

Summary

This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer

Conditions

Interventions

DRUG

Talazoparib

Talazoparib will be taken on days 4-21, 6-21 or 1-21 at a dose level of 0.25, 0.5, 0.75 or 1.0 mg depending on cohort assignment

DRUG

ASTX727

ASTX727 will be taken on days 1 and 3, days 1,3,5 or days 1 through 5 of the 28 day cycle at doses of 10 mg:100 mg or 15 mg:100 mg depending on cohort assignment

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Van Andel Institute Stand Up to Cancer Team

    collaborator UNKNOWN

  • Kathy Miller

    lead OTHER

Principal Investigators

  • Kathy Miller, MD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2024-01-30
Completion
2024-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04134884 on ClinicalTrials.gov