Trial Outcomes & Findings for Pazopanib Maintenance Phase II (NCT NCT02207309)

Results Overview

The study could not be evaluated. Only one patient was included.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months

Results posted on

2024-08-09

Participant Flow

Targeted recruitment goal were 150 patients, 1 patient was randomised

Contrary to the original expectation, patients with retroperitoneal or visceral high-risk soft tissue sarcoma were generally not prepared to undergo further therapy with pazopanib for 2 years after multimodal therapy consisting of 8 cycles of chemotherapy in combination with hyperthermia, surgery and, if necessary, radiotherapy, which may have side effects.

Participant milestones

Participant milestones
Measure	Pazopanib 800mg, oral, 24 months Pazopanib	Placebo 800mg, oral, 24 months Placebo (for Pazopanib)
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib Maintenance Phase II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib n=1 Participants 800mg, oral, 24 months Pazopanib	Placebo 800mg, oral, 24 months Placebo (for Pazopanib)	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months

Population: The study could not be evaluated. Only one patient was included. Contrary to the original expectation, patients with retroperitoneal or visceral high-risk soft tissue sarcoma were generally not prepared to undergo further therapy with pazopanib for 2 years after multimodal therapy consisting of 8 cycles of chemotherapy in combination with hyperthermia, surgery and, if necessary, radiotherapy, which may have side effects.

The study could not be evaluated. Only one patient was included.

Outcome measures

Outcome measures
Measure	Pazopanib n=1 Participants 800mg, oral, 24 months Pazopanib	Placebo 800mg, oral, 24 months Placebo (for Pazopanib)
Progression-free Survival (PFS)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months

The study could not be evaluated. Only one patient was included.

Outcome measures

Outcome data not reported

Adverse Events

Pazopanib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lars Lindner

Ludwigs-Maximilians-Universtity of Munich

Phone: 0049894400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place