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NCT03012230 · ClinicalTrials.gov registry record · Phase 1

Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT03012230: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT03012230 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03012230, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab in treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.

Primary Outcome

Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Interventions

  • BIOLOGICAL Pembrolizumab
  • OTHER Laboratory Biomarker Analysis
  • DRUG Ruxolitinib Phosphate

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-12-06
Est. Completion 2023-03-08
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT03012230 record still lists

NCT03012230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT03012230 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03012230 about?

NCT03012230 is a clinical study titled "Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer". This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab in treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may...

What is the current status of trial NCT03012230?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-12-06. Estimated completion is 2023-03-08.

What interventions are being tested in trial NCT03012230?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Ruxolitinib Phosphate (DRUG).

Who is sponsoring clinical trial NCT03012230?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03012230's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03012230, the US trial registry maintained by the National Library of Medicine. NCT03012230 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.