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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04123704
Other study ID # H-43432
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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