Trial Outcomes & Findings for Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (NCT NCT00668811)
NCT ID: NCT00668811
Last Updated: 2020-08-05
Results Overview
Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
12 months after last patient completes treatment
Results posted on
2020-08-05
Participant Flow
Participant milestones
| Measure |
Treatment Arm - Sutent
Sutent 37.5 mg/day will be given orally.
SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Treatment Arm - Sutent
n=23 Participants
Sutent 37.5 mg/day will be given orally.
SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after last patient completes treatmentProgressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Outcome measures
| Measure |
Treatment Arm - Sutent
n=23 Participants
Sutent 37.5 mg/day will be given orally.
SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
|
|---|---|
|
Progression Free Survival
|
241 days
Interval 114.0 to 518.0
|
SECONDARY outcome
Timeframe: 12 months after last patient completes treatmentOverall survival is defined as the time from the start of treatment to the time to death from any cause or final data collection, whatever happens first.
Outcome measures
| Measure |
Treatment Arm - Sutent
n=23 Participants
Sutent 37.5 mg/day will be given orally.
SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
|
|---|---|
|
Overall Survival
|
1694 days
Interval 505.0 to 1898.0
|
Adverse Events
Treatment Arm - Sutent
Serious events: 2 serious events
Other events: 23 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Treatment Arm - Sutent
n=23 participants at risk
Sutent 37.5 mg/day will be given orally.
SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
|
|---|---|
|
Gastrointestinal disorders
Bowel Obstruction
|
4.3%
1/23 • Number of events 2
|
|
Gastrointestinal disorders
Rectal bleeding
|
4.3%
1/23 • Number of events 1
|
Other adverse events
| Measure |
Treatment Arm - Sutent
n=23 participants at risk
Sutent 37.5 mg/day will be given orally.
SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
82.6%
19/23
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
56.5%
13/23
|
|
General disorders
Fatigue
|
52.2%
12/23
|
|
Gastrointestinal disorders
Diarrhea
|
52.2%
12/23
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal Pain
|
39.1%
9/23
|
|
Skin and subcutaneous tissue disorders
Hand-foot Syndrome
|
39.1%
9/23
|
|
Cardiac disorders
Hypertension
|
26.1%
6/23
|
|
Blood and lymphatic system disorders
Anemia
|
47.8%
11/23
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.2%
15/23
|
|
Blood and lymphatic system disorders
Lymphopenia
|
21.7%
5/23
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
13.0%
3/23
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
4/23
|
|
Gastrointestinal disorders
Anorexia
|
30.4%
7/23
|
|
Gastrointestinal disorders
Constipation
|
30.4%
7/23
|
|
Gastrointestinal disorders
Heartburn
|
17.4%
4/23
|
|
Gastrointestinal disorders
Hemorrhoids
|
13.0%
3/23
|
|
Gastrointestinal disorders
Mucostitis
|
21.7%
5/23
|
|
Gastrointestinal disorders
Nausea
|
39.1%
9/23
|
|
Gastrointestinal disorders
Taste Alteration
|
39.1%
9/23
|
|
Gastrointestinal disorders
Vomiting
|
34.8%
8/23
|
|
Gastrointestinal disorders
GI Hemorrage
|
17.4%
4/23
|
|
Infections and infestations
Infection
|
17.4%
4/23
|
|
Metabolism and nutrition disorders
Increased Alkaline Phosphate
|
17.4%
4/23
|
|
Metabolism and nutrition disorders
Increased ALT
|
47.8%
11/23
|
|
Metabolism and nutrition disorders
Increased AST
|
47.8%
11/23
|
|
Metabolism and nutrition disorders
Increased creatinine
|
43.5%
10/23
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.4%
7/23
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
43.5%
10/23
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.0%
3/23
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.4%
4/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.1%
6/23
|
|
Metabolism and nutrition disorders
Proteinuria
|
21.7%
5/23
|
|
Gastrointestinal disorders
GI Pain
|
26.1%
6/23
|
|
General disorders
General Pain
|
21.7%
5/23
|
|
Gastrointestinal disorders
Nuerological Pain
|
26.1%
6/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
17.4%
4/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.8%
8/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.8%
8/23
|
Additional Information
Dr Kenneth D. Burman
MedStar Washington Hospital Center
Phone: 202-877-8109
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place