Clinical trial NCT04123704: Sitravatinib in Metastatic Breast Cancer
Official title: A Phase II Study of Sitravatinib in Metastatic, Pre-treated, Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer Stage IV
Triple Negative Breast Cancer
Breast Neoplasms
Breast Cancer Metastatic
Keywords: triple negative
metastatic breast cancer
sitravatinib
Lead sponsor: Baylor Breast Care Center
Sponsor class: OTHER
Collaborators: name: Mirati Therapeutics Inc.
First posted: 2019-10-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of sitravatinib in patients with metastatic breast cancer. All study participants will receive sitravatinib, 100 mg daily, until their cancer worsens, or until they develop intolerable side effects.


Eligibility criteria: Inclusion Criteria:

* Women or men age 18 and older
* Metastatic or locally advanced inoperable breast cancer (beyond curative management) that is measurable according to RECIST 1.1 criteria. Note: Patients with bone-only disease are eligible if there is at least 1 lytic lesion that can be followed for response.
* Tumor is estrogen receptor (ER) negative and progesterone receptor (PR) negative per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Guidelines of 2010.
* Tumor is HER2neu negative per ASCO/CAP Guidelines of 2018
* Patient has archival tissue from metastatic or locally advanced breast cancer for the analysis of PTPN12 status
* At least one prior line of chemotherapy with or without a PD-L1 or PD-1 antibody in the metastatic setting
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Normal organ and marrow function as defined below:

  * Absolute neutrophil count \> 1000/mcL
  * Hemoglobin \> 11 g/dL
  * Platelets \> 100,000/mcL
  * Total bilirubin \< 1.5 X normal institutional limits
  * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 X institutional ULN or ≤ 5.0 × ULN for patients with documented liver metastases.
  * Creatinine within normal institutional limits
  * Creatinine clearance ≥ 30 mL/min
  * Normal left ventricular ejection (LVEF) function defined as normal left ventricular wall motion and ejection fraction of ≥ 50%.
* If patient has brain metastasis, documented treatment and stability for at least 30 days by scans and off steroids at the time of enrollment
* Women of child bearing age and actively menstruating must have a negative pregnancy test prior to starting study treatment.
* If sexually active in a way that could lead to pregnancy, participant must agree to use a highly effective method of birth control starting at the time of informed consent and continuing throughout the study and for at least 3 months after the final dose of sitravatinib.
* Ability to understand and the willingness to give informed consent

Exclusion Criteria:

* Uncontrolled hypertension defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100, on two or more occasions within 30 days prior to enrollment.
* Imaging suggestive of Lymphangitic carcinomatosis in the lung, or use of home oxygen
* Untreated brain metastases.
* Women who are pregnant or nursing
* Concurrent metastatic disease of another tumor type
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of sitravatinib
* History of stroke, pulmonary embolus (PE), or myocardial infarction (MI)
* Known proteinuria of ≥ 2 g urinary protein/24 h
* HIV-positive participants
* History of Hepatitis C or Hepatitis B infection
* History of congestive heart failure (CHF), and/or LVEF less than 50%
* Concurrent use of medications that prolong QTc (listed in Section 9, Table 11). These medications need to be discontinued at least 2 weeks prior to starting study treatment.
* Concurrent medical condition that, in the sole judgment of the principal investigator, would make the patient inappropriate for trial participation.

Primary outcomes:
measure: Efficacy: Progression-Free Survival at 24 Weeks (PFS24)
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: Up to 16 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 16 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 16 months
measure: Number of Participants With Grade 3 or Higher AEs
timeFrame: Up to 16 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: C. Kent Osborne, MD
role: PRINCIPAL_INVESTIGATOR
References: