Trial Outcomes & Findings for Phase II Sunitinib Prog Met AIPC (NCT NCT00599313)

Last Updated: 2018-10-25

Results Overview

PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

12 months

Results posted on

2018-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib Malate Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Study STARTED	36
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Malate Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overall Study Adverse Event	19
Overall Study Disease Progression	12
Overall Study Patient Request	4
Overall Study Ineligible	1

Baseline Characteristics

Phase II Sunitinib Prog Met AIPC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib Malate n=36 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Age, Continuous	70.0 years STANDARD_DEVIATION 9.34 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	32 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: ITT population

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=36 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Median Progression-free Survival (PFS) Time at 1-year.	19.4 weeks Interval 2.6 to 48.3

SECONDARY outcome

Timeframe: 12 months

Population: ITT population

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=36 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Overal Survival (OS) Rate at 1-year.	0.42 Probability of Survival at 1-year Interval 0.23 to 0.6

SECONDARY outcome

Timeframe: Baseline and up to 12 months

Population: Evaluable population

Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=33 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Prostate Specific Antigen (PSA) Response	12.1 percentage of participants Interval 3.4 to 28.2

SECONDARY outcome

Timeframe: Baseline and up to 12 months

Population: Patients who had measurements of prior and post doubling time.

Difference of PSA doubling time between baseline and end of the treatment.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=25 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Change of PSA Doubling Time	0.5 months Interval -5.1 to 43.7

SECONDARY outcome

Timeframe: 12 months

Population: Only patients with baseline measurable lesions.

ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=18 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Objective Response Rate (ORR)	11.1 percentage of participants Interval 1.4 to 34.7

SECONDARY outcome

Timeframe: Baseline and up to 12 months

Population: Patients with pain measurement at baseline.

Pain score decreased \>=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week's average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week's period.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=22 Participants Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.	13.6 percentage of participants Interval 6.3 to 20.9

Adverse Events

Sunitinib Malate

Serious events: 7 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib Malate n=35 participants at risk Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Gastrointestinal disorders ABDOMINAL PAIN	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Musculoskeletal and connective tissue disorders BACK PAIN	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DEHYDRATION	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DIARRHEA	5.7% 2/35 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Renal and urinary disorders FAILURE KIDNEY ACUTE	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA AND VOMITING	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Infections and infestations SEPSIS	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Vascular disorders STROKE	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Respiratory, thoracic and mediastinal disorders THROMBOSIS PULMONARY	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	2.9% 1/35 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.

Other adverse events

Other adverse events
Measure	Sunitinib Malate n=35 participants at risk Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
Metabolism and nutrition disorders ALKALINE PHOSPHASTASE SERUM INCREASE	5.7% 2/35 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders ANEMIA	37.1% 13/35 • Number of events 17 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders ANOREXIA	37.1% 13/35 • Number of events 18 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders CONSTIPATION	5.7% 2/35 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DIARRHEA	31.4% 11/35 • Number of events 13 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DYSGUESIA	8.6% 3/35 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders EDEMA	5.7% 2/35 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders FATIGUE	45.7% 16/35 • Number of events 25 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders HAND-FOOT SYNDROME	8.6% 3/35 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Vascular disorders HYPERTENSION	8.6% 3/35 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders LEUCOPENIA	14.3% 5/35 • Number of events 14 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders MALAISE	5.7% 2/35 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders MUCOSITIS	17.1% 6/35 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS	5.7% 2/35 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Musculoskeletal and connective tissue disorders MYALGIA	11.4% 4/35 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA	34.3% 12/35 • Number of events 20 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Nervous system disorders NEUROPATHY	5.7% 2/35 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders NEUTROPENIA	31.4% 11/35 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders RASH	17.1% 6/35 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders STOMATITIS	5.7% 2/35 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders THROMBOCYTOPENIA	11.4% 4/35 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	14.3% 5/35 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders WEIGHT LOSS	11.4% 4/35 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.

Additional Information

Dr. Guru Sonpavde

Texas Oncology Cancer Center

Phone: 2813327505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place