Onvansertib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana-Farber Cancer Institute, Boston, MA
Breast Cancer+13 More
Onvansertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is being done to see if Onvansertib in combination with Paclitaxel is safe and effective in treating TNBC that has spread to other parts of the body. Onvansertib is used to treat Breast Cancer and has previously been approved by the FDA for a different condition. No patients in this trial will receive a placebo. This treatment is free.

Eligible Conditions

  • Breast Cancer
  • Malignant Neoplasms
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Breast
  • Hormone Receptor Negative Breast Carcinoma
  • erbB-2 Receptor
  • BRCA1 gene
  • Inflammatory Breast Cancer (IBC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Every 8 weeks until disease progression, in average 24 weeks

Week 24
Incidence of Grade 3 or Higher Treatment-Related Toxicity-Phase II
Week 24
Median Progression-free survival (PFS)-Phase II
Overall Response Rate (ORR) Phase II
Day 28
AUC-Phase Ib
Cmax-Phase Ib
Day 28
Dose-Limiting Toxicity (DLT)-Phase Ib
Incidence of Grade 3 or Higher Treatment-Related Toxicity- Phase Ib

Trial Safety

Trial Design

2 Treatment Groups

DOSE EXPANSION RP2D ONVANSERTIB + PACLITAXEL
1 of 2
DOSE ESCALATION ONVANSERTIB + PACLITAXEL
1 of 2
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Onvansertib · No Placebo Group · Phase 1 & 2

DOSE EXPANSION RP2D ONVANSERTIB + PACLITAXELExperimental Group · 2 Interventions: Onvansertib, Paclitaxel · Intervention Types: Drug, Drug
DOSE ESCALATION ONVANSERTIB + PACLITAXELExperimental Group · 2 Interventions: Onvansertib, Paclitaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2017
Completed Phase 2
~80
Paclitaxel
2011
Completed Phase 4
~6340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks until disease progression, in average 24 weeks
Closest Location: Dana-Farber Cancer Institute · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2007First Recorded Clinical Trial
125 TrialsResearching Breast Cancer
932 CompletedClinical Trials

Who is running the clinical trial?

Cardiff OncologyIndustry Sponsor
7 Previous Clinical Trials
405 Total Patients Enrolled
Antonio Giordano, MDLead Sponsor
Antonio C Giordano, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects with treated brain metastases that are stable on imaging for at least four weeks prior to registration and who are off steroid therapy are eligible.
You must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days of the final dose of any study drug.
Breast cancer with histologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease, included inflammatory breast cancer.
You have no signs or symptoms of cancer.
Subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Patients with ER/PR ≥1% will not be allowed to receive concurrent endocrine therapy.
Subjects are allowed to participate in surveys or observational studies.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.