Clinical trial NCT02524951: Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
Official title: A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: DepYmed Inc.
First posted: 2015-08-17
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.

Detailed description: This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436. Drug infusions will last approximately 2 hours. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436 will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.

Eligibility criteria: Inclusion Criteria:

* Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).
* Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination.

A metastatic site must be biopsy proven

* Life expectancy ≥3 months.
* Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.
* Female Age ≥18 years.
* Stable brain metastasis is permitted. This is not considered measurable disease.

Stable brain metastasis is defined as no change on CT scan or MRI for minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks

* A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age \< 55 or with no menses for \< 1 year
* Screening laboratory values as follows:

Total bilirubin ≤1.5 times upper limit of normal (ULN). Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times ULN.

Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. Absolute neutrophil count \>1,500 cells/mm3. Platelet count ≥100,000 plt/mm3. Hemoglobin ≥ 8 g/dL. Non-diabetic

Exclusion Criteria:

* Pregnant or breast-feeding
* ECOG Performance Status greater than 2

Primary outcomes:
measure: Maximally Tolerated Dose (MTD) of MSI-1436
timeFrame: one year
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: one year
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: one year
measure: response rates
timeFrame: one year
measure: Peak plasma concentration of the drug after administration (cmax)
timeFrame: one year
measure: Time to reach cmax
timeFrame: one year
measure: Time required for the concentration of MSI-1436C to reach half of its original value, or half life (t1/2)
timeFrame: one year
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: CFAM / Monter Cancer Center
state: New York
Study officials:
affiliation: North Shore LIJ Cancer Institute
name: Daniel Budman, MD
role: PRINCIPAL_INVESTIGATOR
References: