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Bone MetastasesPhase 1NCT03292536

Merestinib on Bone Metastases in Subjects With Breast Cancer

A Phase 1 study testing Merestinib in people with Bone Metastases and Breast Cancer, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open label, pharmacodynamics, intrapatient dose escalation phase 1B study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Bone Metastases, Breast Cancer
What is being tested?
Merestinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
11 Jan 2018to 24 Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 1 bone metastases must be present
  • Urinary N-telopeptide level above 20nM BCE/mM creatinine measured at ARUP
  • Archived or freshly biopsied primary and/or bone metastatic tumor tissue available in paraffin-embedded blocks or slides that is expected to yield 9 slides
  • Life expectancy of ≥ 6 months
  • Toxicity related to prior treatments must either have resolved to grade 1 or less, returned to baseline, or be deemed irreversible
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 28 days prior to enrollment)
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  • Planning to remain on current breast cancer therapy for at least 12 weeks.
  • At least one prior line of therapy for metastatic breast cancer
  • Concurrent treatment with bisphosphonates or denosumab is required.

Who cannot join

  • Unable to swallow or take anything orally
  • ECG abnormalities:
  • Prolonged QTcF (Fredericia's correction) interval on screening ECG (≥ 450 msec)
  • QRS ˃ 120 msec
  • PR ˃ 210 msec
  • Any prior history, or current evidence of second- or third-degree heart block
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  • Heart rate ˂ 40 beats per minute at screening
  • ECG second degree heart block (Mobitz's Type 2 or Wenckebach)
  • Complete heart block
  • Left bundle branch block or bifascicular block (right bundle branch block and left anterior hemiblock together)
  • Episodes of ventricular tachycardia
  • Any known prior malignancy (not including non-melanoma skin cancers), unless treated with curative intent
  • A serious uncontrolled medical disorder or active infection, which would impair the ability of the subject to receive protocol therapy
  • Current or recent (within 3 months) gastrointestinal disease that could impact the absorption (i.e., unmanageable diarrhea or malabsorption at the time of screening)
  • Inadequate bone marrow function defined as:
  • Absolute neutrophil count (ANC) ˂ 1,500 cells/mm3
  • Platelet count ˂ 100,000 cells/mm3
  • Hemoglobin ˂ 9 g/dL
  • Inadequate hepatic function defined as:
  • Total bilirubin ˃ 1.5 x institutional upper limit of normal (IULN) (Unless due to diagnosis of Gilbert's Syndrome)
  • Alanine aminotransaminase (ALT) and aspartate aminotransaminase (AST) ˃ 2.5 x IULN
  • Inadequate renal function defined as: Serum creatinine ˃ 1.5 x ULN
  • Prothrombin time (PT)/partial thromboplastin time (PTT) ˃ 1.5 times the ULN
  • Serum sodium, potassium, and calcium levels not within normal limits.
  • Any atrophic macular condition including intermediate or advanced age-related macular degeneration
  • Patients receiving medications that are known to be substrates of CYP2C8 (including paclitaxel), CYP2C9, or CYP2C19 or to be oral substrates of CYP3A with narrow therapeutic window (listed on http://medicine.iupui.edu/clinpharm/ddis/main-table). Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of merestinib
  • Exposure to any investigational drug or placebo within 4 weeks of enrollment
  • Any other sound medical, psychiatric, and/or social reasons as determined by the investigator
  • History of diseases with influence on bone metabolism, such as Paget's disease, osteogenesis imperfecta, active primary or secondary hyperparathyroidism, and primary or secondary hyperthyroidism within 12 months prior to study entry
  • Patients with known symptomatic brain metastasis. Subjects with controlled brain metastasis (no radiographic progression at least 4 weeks following radiation and/or surgical treatment and no neurological signs or symptoms) will be allowed
  • History of allergy to merestinib or chemically related compounds
  • History of osteonecrosis of the jaw
  • Change in chemotherapy or hormone therapy within 8 weeks of the start of the study.
  • Active gout or inflammatory arthritis requiring treatment
  • Use within 28 days of registration of calcitonin, recombinant parathyroid hormone-related peptides, mithramycin, radium, strontium ranelate, or gallium nitrate.
  • Adult patients who require monitored anesthesia for PET scanning due to claustrophobia.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: An Exploratory Phase 1B Study to Assess the Effects of Merestinib on Bone Metastases in Subjects With Breast Cancer

This is an open label, pharmacodynamics, intrapatient dose escalation phase 1B study.

Being tested
Merestinib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MerestinibDrug

    *The merestinib does escalation timing will depend on the schedule of the other anticancer regimen*

    Subjects will receive merestinib 40mg PO Qday (dose level 1) for 2 to 4 weeks followed by 80mg PO daily (dose level 2) for 4 to 10 weeks

Study groups in NCT03292536
Study groupRoleWhat they receive
Merestinib, all patientsExperimentalNot described
Receives: Drug: Merestinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events that Occur

    To assess the tolerability of merestinib in combination with standard breast cancer therapies.

    Measured: 12 weeks, checked at every visit in that time period

  2. Change in urinary N-telopeptide level

    To measure the change in urinary N-telopeptide level after 12 weeks of therapy with merestinib

    Measured: 12 weeks

Secondary outcomes (5)

  1. Absolute and percentage change in serum B-CTX, TRAP-5b, P1NP and BSAP

    To measure the absolute and percentage change in serum β-CTX, TRAP-5b, P1NP, and BSAP at time points from baseline to 12 weeks.

    Measured: 12 weeks

  2. Time to skeletal-related events

    To evaluate determine time to skeletal-related event(s) following initiation of merestinib dosing

    Measured: 12 weeks

  3. Change in pain scores

    To evaluate change in pain as measured by pain scores during and after 12 weeks of merestinib treatment

    Measured: 12 weeks

  4. Change in pain by narcotic use

    To evaluate change in pain as measured by narcotic use) during and after 12 weeks of merestinib treatment

    Measured: 12 weeks

  5. Change in bone lesion uptake

    To evaluate the change in bone lesion uptake on NaF PET scan after 12 weeks of merestinib treatment

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start11 Jan 2018
  3. Primary completion24 Jun 2019
  4. Study completion24 Jun 2019

Why it stopped: Enrollment incomplete by the end of the contracted enrollment period

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
a single arm, open label, pharmacodynamics, intrapatient dose escalation phase 1B study
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292536
Sponsor's protocol ID
HCI103657
Status last verified
Jan 2021
First submitted
20 Sep 2017
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Merestinib in people with Bone Metastases and Breast Cancer, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Enrollment incomplete by the end of the contracted enrollment period). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events that Occur (time frame: 12 weeks, checked at every visit in that time period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03292536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.

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