Trial Outcomes & Findings for Sitravatinib in Metastatic Breast Cancer (NCT NCT04123704)

Last Updated: 2024-08-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

24 weeks

Results posted on

2024-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Sitravatinib Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitravatinib Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Overall Study Disease progression	2

Baseline Characteristics

Sitravatinib in Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitravatinib n=3 Participants Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Age, Continuous	53.33 years STANDARD_DEVIATION 8.62 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Sitravatinib n=3 Participants Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Efficacy: Progression-Free Survival at 24 Weeks (PFS24)	33.3 percentage of participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: Up to 16 months

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.

Outcome measures

Outcome measures
Measure	Sitravatinib n=3 Participants Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Time to Progression (TTP)	24.6 weeks Standard Deviation 16.3

SECONDARY outcome

Timeframe: Up to 16 months

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.

Outcome measures

Outcome measures
Measure	Sitravatinib n=3 Participants Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Objective Response Rate (ORR)	33.3 percentage of participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: Up to 16 months

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.

Outcome measures

Outcome measures
Measure	Sitravatinib n=3 Participants Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Clinical Benefit Rate (CBR)	66.7 percentage of participants Interval 9.4 to 99.2

SECONDARY outcome

Timeframe: Up to 16 months

Adverse events will be assessed and graded per the NCI CTCAEv5.

Outcome measures

Outcome measures
Measure	Sitravatinib n=3 Participants Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Number of Participants With Grade 3 or Higher AEs	2 Participants

Adverse Events

Sitravatinib

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Sitravatinib n=3 participants at risk Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).

Other adverse events

Other adverse events
Measure	Sitravatinib n=3 participants at risk Sitravatinib 100 mg daily Sitravatinib: sitravatinib capsule
Endocrine disorders Hypothyroidism	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 3 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Infections and infestations Skin infection	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 2 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Investigations Aspartate aminotransferase increased	100.0% 3/3 • Number of events 4 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Investigations Thyroid stimulating hormone increased	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Musculoskeletal and connective tissue disorders Muscle cramp	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	66.7% 2/3 • Number of events 2 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).
Vascular disorders Hypertension	100.0% 3/3 • Number of events 13 • Adverse events were assessed starting at beginning of treatment until 30 days after disease progression or at study completion (up to 16 months), whichever comes first. All-cause mortality was assessed at study completion (up to 16 months from the treatment start date).

Additional Information

Dr. C. Kent Osborne

Baylor College of Medicine, Dan L Duncan Comprehensive Cancer Center

Phone: 713-798-1640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place