Trial Outcomes & Findings for Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer (NCT NCT00854620)

Last Updated: 2015-06-19

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

12 months

Results posted on

2015-06-19

Participant milestones
Measure	Sorafenib * Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Sorafenib * Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
Overall Study Adverse Event	1

Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

Baseline characteristics by cohort
Measure	Sorafenib n=9 Participants * Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

Timeframe: 12 months

Outcome measures
Measure	Sorafenib n=9 Participants * Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
Time-to-progression (TTP)	5.3 months Interval 0.9 to 9.5

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Sorafenib n=9 participants at risk * Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
General disorders General disorders and administration site conditions-other, Hand foot Syndrome	100.0% 9/9 • Number of events 10
Skin and subcutaneous tissue disorders Rash maculo-papular	44.4% 4/9 • Number of events 4
Skin and subcutaneous tissue disorders Pruritus	44.4% 4/9 • Number of events 4
Gastrointestinal disorders Diarrhea	100.0% 9/9 • Number of events 15
Vascular disorders Hypertension	77.8% 7/9 • Number of events 7
Skin and subcutaneous tissue disorders Alopecia	66.7% 6/9 • Number of events 6
Metabolism and nutrition disorders Hypercalcemia	11.1% 1/9 • Number of events 1
General disorders Fatigue	44.4% 4/9 • Number of events 4
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1
Skin and subcutaneous tissue disorders Dry skin	22.2% 2/9 • Number of events 2
Gastrointestinal disorders Nausea	33.3% 3/9 • Number of events 3
Nervous system disorders Dysgeusia	33.3% 3/9 • Number of events 3
Investigations Weight loss	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Oral pain	22.2% 2/9 • Number of events 2
Gastrointestinal disorders Flatulence	22.2% 2/9 • Number of events 2
Vascular disorders Flushing	11.1% 1/9 • Number of events 1

Stanford University, Stanford Cancer Center

Phone: 650-725-2078