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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
sitravatinib capsule
Baylor College of Medicine
Houston, Texas, United States
Efficacy: Progression-Free Survival at 24 Weeks (PFS24)
Progression-free survival 24 weeks after starting study treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Progressive Disease, \>=20% increase in the sum of the smallest diameter of target lesions, or appearance of one or more new lesions.
Time frame: 24 weeks
Time to Progression (TTP)
Time to progression is defined as the duration of time from initiation of study treatment until progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Progressive Disease, \>=20% increase in the sum of the smallest diameter of target lesions, or appearance of one or more new lesions.
Time frame: Up to 16 months
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) to treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 16 months
Clinical Benefit Rate (CBR)
Clinical benefit rate is defined as the percentage of participants who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither \>=30% decrease in sum of longest diameter of target lesions nor \>=20% increase in sum of shortest diameter of target lesions.
Time frame: Up to 16 months
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Number of Participants With Grade 3 or Higher AEs
Adverse events will be assessed and graded per the NCI CTCAEv5.
Time frame: Up to 16 months