Trial Outcomes & Findings for Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine (NCT NCT00098813)
NCT ID: NCT00098813
Last Updated: 2014-05-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From start of treatment to 8 weeks
Results posted on
2014-05-28
Participant Flow
Protocol Open to Accrual 10/12/2004 Protocol Closed to Accrual 04/22/2008 Primary Completion Date 08/11/2009 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Treatment (Romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Treatment (Romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Progression of Disease
|
1
|
|
Overall Study
Other complicating disease
|
1
|
|
Overall Study
Reversal of RAI resistance
|
1
|
Baseline Characteristics
Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine
Baseline characteristics by cohort
| Measure |
Treatment (Romidepsin)
n=20 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 34.64823228 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to 8 weeksOutcome measures
| Measure |
Treatment (Romidepsin)
n=11 Participants
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria
Stable Disease
|
10 participants
|
|
Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria
Progression of Disease
|
1 participants
|
Adverse Events
Treatment (Romidepsin)
Serious events: 12 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Romidepsin)
n=20 participants at risk
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Investigations
AST, SGOT
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Death-Sudden Death
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Death-Disease Progression
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Fistula, GI-Small bowel NOS
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Lymphocyte count decrease
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Neuropathy-motor
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Platelet count decrease
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Prolonged QTc interval
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Romidepsin)
n=20 participants at risk
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
|---|---|
|
Investigations
ALT, SGPT
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
35.0%
7/20 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
5/20 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemoglobin decrease
|
10.0%
2/20 • Number of events 2
|
|
Investigations
White blood cell decrease
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Lymphocyte decrease
|
35.0%
7/20 • Number of events 7
|
|
Investigations
Neutrophil count decrease
|
15.0%
3/20 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
30.0%
6/20 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1
|
Additional Information
Dr. David Pfister
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60