Protocol Summary

Protocol No.

103657 (ExIST; Merestinib Breast)

Principal Investigator

Cohen, Adam

Phase

I

Age Group

Adult

ClinicalTrials.Gov

NCT03292536 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Title

Exploratory Phase IB Study to Assess the Effects of Merestinib on Bone Metastases in Subjects with Breast Cancer

Objective

Primary Objectives and Endpoint
1. To assess the tolerability of merestinib in combination with standard breast cancer therapies.
2. To measure the change in urinary N-telopeptide level after 12 weeks of therapy with merestinib

Secondary Objectives and Endpoint
1. To measure the absolute and percentage change in serum CTX, TRAP-5b, P1NP, and BSAP at time points from baseline to 12 weeks
2. To evaluate determine time to skeletal-related event(s) following initiation of merestinib dosing
3. To evaluate change in pain (as measured by pain scores and narcotic use) during and after 12 weeks of merestinib treatment
4. To evaluate the change in bone lesion uptake on NaF PET scan after 12 weeks of merestinib treatment.
5. To measure MSP levels in serum/plasma and tumor (when available) and determine whether MSP levels correlate with response to merestinib.
6. To measure RON and pRON levels in pretreatment tumor biopsy samples (when available) and determine whether RON or pRON levels correlate with response to merestinib.
7. To collect peripheral blood leukocytes at time points for future immunophenotyping, to assess markers of immune response.
8. To collect tumor biopsy samples (when available) for future assessment of tumor-infiltrating lymphocytes (TILs) and determine whether TILs correlate with response to merestinib and to compare TIL clones using single cell sequencing.

Applicable Disease Sites

Breast; Experimental Therapeutics

Participating Institutions

HCI Farmington; HCI South Jordan; Huntsman Cancer Institute

Status

Open


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