Merestinib on Bone Metastases in Subjects With Breast Cancer

Stopped early · Phase 1

Conditions studied: Bone Metastases, Breast Cancer

In brief

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

Key facts

Study ID

NCT03292536

Run by

University of Utah

People needed

2

Starts

2018-01-11

Expected to finish

2019-06-24

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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:
• 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

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.