Trial Outcomes & Findings for SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes (NCT NCT02644122)

NCT ID: NCT02644122

Last Updated: 2018-07-11

Results Overview

best response of PR or CR observed within 6 months of enrollment

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-07-11

Participant Flow

Participant milestones

Measure	SF1126 SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	SF1126 SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes

Baseline characteristics by cohort

Measure	SF1126 n=1 Participants SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

best response of PR or CR observed within 6 months of enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Measure	SF1126 n=1 Participants SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
Number of Participants With Treatment-related Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

Adverse Events

SF1126

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	SF1126 n=1 participants at risk SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles. SF1126
Cardiac disorders dyspnea	100.0% 1/1 • Number of events 1
Cardiac disorders atrial fibrilation	100.0% 1/1 • Number of events 1

Other adverse events

Measure	SF1126 n=1 participants at risk SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles. SF1126
Blood and lymphatic system disorders anemia	100.0% 1/1 • Number of events 1
Respiratory, thoracic and mediastinal disorders wheezing	100.0% 1/1 • Number of events 1
Cardiac disorders cardiac troponin T increased	100.0% 1/1 • Number of events 1

Additional Information

Ezra Cohen, MD

University of California, San Diego

Phone: (858)822-5800

Email: ecohen@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place