Trial Outcomes & Findings for Sunitinib Non Small Cell Lung Cancer Patients Over 70 (NCT NCT00864721)

Last Updated: 2018-10-16

Results Overview

Disease control rate = CR + PR + SD\>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Every 6 weeks until progressive disease or death due to any cause, up to 36 month.

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib Malate Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Overall Study STARTED	63
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Malate Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Overall Study Patient request	11
Overall Study Hospitalized	1
Overall Study Drug hold/delay more than 4 weeks	1
Overall Study Adverse Event	21

Baseline Characteristics

Sunitinib Non Small Cell Lung Cancer Patients Over 70

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib Malate n=63 Participants Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Age, Continuous	78.7 years STANDARD_DEVIATION 5.08 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	60 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 6 weeks until progressive disease or death due to any cause, up to 36 month.

Population: Evaluable population

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=60 Participants Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Disease Control Rate (DCR)	63.3 percentage of participants Interval 49.9 to 75.4

SECONDARY outcome

Timeframe: Every 6 weeks until progressive disease or death due to any causes, up to 36 months.

Population: Evaluable population

Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=60 Participants Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Overall Response Rates (OR)	6.7 percentage of participants Interval 1.8 to 16.2

SECONDARY outcome

Timeframe: All patients were followed until progressive disease or death, up to 36 months.

Population: ITT population

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 the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=63 Participants Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Progression-free Survival (PFS)	3.0 months Interval 0.1 to 25.1

SECONDARY outcome

Timeframe: All patients were followed until death or up to 36 months.

Population: ITT population

OS is measured from the date of registration 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 date of last contact.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=63 Participants Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
1-year Overall Survival (OS) Rate.	26 percentage of participants alive at 1yr Interval 16.0 to 38.0

SECONDARY outcome

Timeframe: All patients were followed until progressive disease or death, up to 36 months.

Population: ITT population

TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Sunitinib Malate n=63 Participants Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Time to Progression (TTP)	4.5 months Interval 0.1 to 25.1

Adverse Events

Sunitinib Malate

Serious events: 11 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib Malate n=60 participants at risk Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Gastrointestinal disorders ABDOMINAL PAIN	1.7% 1/60 • 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.
Blood and lymphatic system disorders ANEMIA HEMOLYTIC (NOS)	1.7% 1/60 • 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 APPETITE DECREASED	3.3% 2/60 • 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 BLEEDING GASTROINTESTINAL	1.7% 1/60 • 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.
Cardiac disorders CARDIAC FAILURE	1.7% 1/60 • 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 COLITIS ULCERATIVE	1.7% 1/60 • 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	3.3% 2/60 • 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	5.0% 3/60 • 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.
Infections and infestations DIVERTICULITIS	1.7% 1/60 • 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.
General disorders FATIGUE	3.3% 2/60 • 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 HEMORRHAGE (NOS)	1.7% 1/60 • 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 JAUNDICE	1.7% 1/60 • 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 MUCOSITIS ORAL	1.7% 1/60 • 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.
General disorders PAIN HEAD	1.7% 1/60 • 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.
Blood and lymphatic system disorders THROMBOCYTOPENIA	5.0% 3/60 • 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.
Gastrointestinal disorders VOMITING	1.7% 1/60 • 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=60 participants at risk Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Blood and lymphatic system disorders ANEMIA	8.3% 5/60 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders ANOREXIA	21.7% 13/60 • Number of events 23 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders CONSTIPATION	13.3% 8/60 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DEHYDRATION	6.7% 4/60 • 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.
Gastrointestinal disorders DIARRHEA	30.0% 18/60 • Number of events 26 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DYSGUESIA	13.3% 8/60 • 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.
Skin and subcutaneous tissue disorders ERYTHEMA	5.0% 3/60 • 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.
General disorders FATIGUE	43.3% 26/60 • Number of events 53 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX	6.7% 4/60 • 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.
General disorders HEADACHE	5.0% 3/60 • 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.
Infections and infestations INFECTION FUNGAL	6.7% 4/60 • 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 INSOMNIA	5.0% 3/60 • 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.
Infections and infestations MUCOSITIS	23.3% 14/60 • 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.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS	5.0% 3/60 • 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.
Gastrointestinal disorders NAUSEA	23.3% 14/60 • Number of events 19 • 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	6.7% 4/60 • 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.
Blood and lymphatic system disorders NEUTROPENIA	15.0% 9/60 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders PAIN MOUTH	5.0% 3/60 • 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.
Renal and urinary disorders PROTEINURIA	5.0% 3/60 • 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.
Skin and subcutaneous tissue disorders RASH	6.7% 4/60 • 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.
Blood and lymphatic system disorders THROMBOCYTOPENIA	26.7% 16/60 • Number of events 24 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	13.3% 8/60 • Number of events 12 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders WEAKNESS	10.0% 6/60 • Number of events 7 • 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	10.0% 6/60 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.

Additional Information

Dr. Craig Reynolds

Ocala Oncology, Ocala, FL, USA

Phone: 352-732-4032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place