NCT03292536

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

September 20, 2017

Last Update Submit

January 7, 2021

Conditions

Bone MetastasesBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • Adverse Events that Occur

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

    12 weeks, checked at every visit in that time period

  • Change in urinary N-telopeptide level

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

    12 weeks

Secondary Outcomes (5)

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

    12 weeks

  • Time to skeletal-related events

    12 weeks

  • Change in pain scores

    12 weeks

  • Change in pain by narcotic use

    12 weeks

  • Change in bone lesion uptake

    12 weeks

Study Arms (1)

Merestinib, all patients

EXPERIMENTAL
Drug: Merestinib

Interventions

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

Merestinib, all patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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
  • 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:
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

merestinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: a single arm, open label, pharmacodynamics, intrapatient dose escalation phase 1B study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

January 11, 2018

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)