Trial Outcomes & Findings for Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission (NCT NCT00522301)

Results Overview

All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

1 year

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Sorafenib (BAY43-9006) Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Sorafenib (BAY43-9006) Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	5

Baseline Characteristics

Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Sorafenib (BAY43-9006) n=6 Participants Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Protocol terminated prior to primary outcome evaluation. All 5 patient were evaluable for toxicity only.

All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.

Outcome measures

Outcome data not reported

Adverse Events

Oral Sorafenib (BAY43-9006)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Sorafenib (BAY43-9006) n=5 participants at risk Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	20.0% 1/5 • Number of events 1

Other adverse events

Other adverse events
Measure	Oral Sorafenib (BAY43-9006) n=5 participants at risk Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
Skin and subcutaneous tissue disorders Rash	100.0% 5/5 • Number of events 5
Nervous system disorders Dizziness	100.0% 5/5 • Number of events 5
General disorders Pain	40.0% 2/5 • Number of events 2
General disorders Fatigue	100.0% 5/5 • Number of events 5
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	100.0% 5/5 • Number of events 5
Metabolism and nutrition disorders Alkaline Phosphatase	100.0% 5/5 • Number of events 5

Additional Information

Dr. William Tew

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place