Trial Outcomes & Findings for Sunitinib in Refractory Adrenocortical Carcinoma (NCT NCT00453895)

Results Overview

Clinical benefit was defined as stable disease or better for at least 12 weeks

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-01-31

Participant Flow

The first patient was included in the study on July 17, 2007, the last patient enrolled on September 18, 2009. The last patient stopped the study drug on November 20, 2009.

Participant milestones

Participant milestones
Measure	Sunitinib Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sunitinib in Refractory Adrenocortical Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=39 Participants Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	51.3 years STANDARD_DEVIATION 12.4 • n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Region of Enrollment Germany	39 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks

Clinical benefit was defined as stable disease or better for at least 12 weeks

Outcome measures

Outcome measures
Measure	Sunitinib n=35 Participants Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Assessment of Clinical Benefit Due to Treatment With Sunitinib	5 Participants

SECONDARY outcome

Timeframe: 12 weeks

Objective Response Rate defined by RECIST 1.0

Outcome measures

Outcome measures
Measure	Sunitinib n=35 Participants Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Assessment of Objective Response Rates	0 Participants

SECONDARY outcome

Timeframe: up to 400 days

Progression-free survival is defined as time of start of study until documentation of Progress. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Sunitinib n=35 Participants Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Assessment of Progression-free Survival	83 days Interval 80.0 to 85.0

SECONDARY outcome

Timeframe: up to 36 months

Overall Survival was defined as time from start of treatment until death or last follow-up.

Outcome measures

Outcome measures
Measure	Sunitinib n=35 Participants Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Assessment of Overall Survival	5.4 monhts Interval 3.2 to 7.6

SECONDARY outcome

Timeframe: up to 400 days

Adverse events were rated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (see http://ctep.cancer.gov/reporting/ctc.html).

Outcome measures

Outcome measures
Measure	Sunitinib n=39 Participants Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Assessment of Toxicity	4 number of adverse events/patient Interval 0.0 to 10.0

Adverse Events

Sunitinib

Serious events: 10 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=39 participants at risk Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Cardiac disorders myocard infarcton	2.6% 1/39 • Number of events 1 • up to 1 year
Endocrine disorders hypogylcimia	2.6% 1/39 • Number of events 1 • up to 1 year
Nervous system disorders Dizziness/drowsiness	5.1% 2/39 • Number of events 2 • up to 1 year
General disorders Fatigue	5.1% 2/39 • Number of events 2 • up to 1 year
Gastrointestinal disorders diarrhea	5.1% 2/39 • Number of events 2 • up to 1 year
General disorders liver failure	2.6% 1/39 • Number of events 1 • up to 1 year
Endocrine disorders adrenal insufficiency	2.6% 1/39 • Number of events 1 • up to 1 year

Other adverse events

Other adverse events
Measure	Sunitinib n=39 participants at risk Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity Sunitinib :
Nervous system disorders Polyneuropathy	25.6% 10/39 • Number of events 11 • up to 1 year
General disorders Pain	25.6% 10/39 • Number of events 15 • up to 1 year
Gastrointestinal disorders Diarrhea	23.1% 9/39 • Number of events 9 • up to 1 year
Skin and subcutaneous tissue disorders rash or discolored nails	23.1% 9/39 • Number of events 9 • up to 1 year
General disorders fatigue	7.7% 3/39 • Number of events 3 • up to 1 year
Skin and subcutaneous tissue disorders mucositis	10.3% 4/39 • Number of events 4 • up to 1 year
Blood and lymphatic system disorders Anemia, Thrombopenia, Leukopenia	10.3% 4/39 • Number of events 4 • up to 1 year
Blood and lymphatic system disorders hemorrhage	7.7% 3/39 • Number of events 3 • up to 1 year

Additional Information

Prof. Dr. Martin Fassnacht

University of Würzburg

Phone: +49-931-201-39201

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place