Sitravatinib in Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Phase II Study of Sitravatinib in Metastatic, Pre-treated, Triple Negative Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04123704
• Other study ID #: H-43432
• Status: Terminated
• Phase: Phase 2
• Start date: September 22, 2021
• Est. completion date: January 22, 2023

Study information

• Verified date: May 2024
• Source: Baylor Breast Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 22, 2023
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Metastatic
• Breast Cancer Stage IV
• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Sitravatinib
sitravatinib capsule

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Xiang Zhang	Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Progression-Free Survival at 24 Weeks (PFS24)	Progression-free survival 24 weeks after starting study treatment, as evaluated by RECIST 1.1 criteria.	24 weeks
Secondary	Time to Progression (TTP)	Time to progression is defined as the duration of time from initiation of study treatment until progression, according to RECIST 1.1 criteria.	Up to 5 years
Secondary	Objective Response Rate (ORR)	Objective response rate is defined as the proportion of participants who achieve a Complete Response (CR) or Partial Response (PR) to treatment per RECIST 1.1 criteria.	Up to 5 years
Secondary	Clinical Benefit Rate (CBR)	Clinical benefit rate is defined as the proportion of participants who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1 criteria.	Up to 5 years
Secondary	Number of Participants with Grade 3 or Higher AEs	Adverse events will be assessed and graded per the NCI CTCAEv5.	Up to 5 years