Trial Outcomes & Findings for Trial Evaluating Gleevec in Patients With Anaplastic Thyroid Carcinoma (NCT NCT00115739)
NCT ID: NCT00115739
Last Updated: 2014-04-21
Results Overview
The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-04-21
Participant Flow
Potential participants at the Comprehensive Cancer Center outpatient Oncology Clinics at the University of Michigan Health Systems were approached with a brief discussion of the study. If interested, a more detailed discussion of the risks \& benefits of the study took place with the subject as well as any family members that may have been present.
Participant milestones
| Measure |
Imatinib (Gleevec) Tablets
4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Imatinib (Gleevec) Tablets
4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Trial Evaluating Gleevec in Patients With Anaplastic Thyroid Carcinoma
Baseline characteristics by cohort
| Measure |
Imatinib (Gleevec) Tablets
n=11 Participants
patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Eight patients completed 8 weeks of imatinib and were considered evaluable for response.
The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.
Outcome measures
| Measure |
Imatinib (Gleevec) Tablets
n=8 Participants
Subjects were administered oral Gleevec tablets, then tumor response was assessed
|
|---|---|
|
Overall Response (Complete and Partial Response) Rate at 8 Weeks
Number of Participants with CR
|
0 participants
Interval 9.0 to 65.0
|
|
Overall Response (Complete and Partial Response) Rate at 8 Weeks
Number of Participants with PR
|
2 participants
|
|
Overall Response (Complete and Partial Response) Rate at 8 Weeks
Number of Participants with SD
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 30 days post treatmentPopulation: Patients receiving at least one dose of imatinib were included in toxicity analysis.
Number of grade 3, grade 4 and grade 5 toxicities experienced by patients with anaplastic thyroid cancer who are treated with Gleevec.
Outcome measures
| Measure |
Imatinib (Gleevec) Tablets
n=11 Participants
Subjects were administered oral Gleevec tablets, then tumor response was assessed
|
|---|---|
|
Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec
Number of Grade 3 Toxicities Reported
|
29 events
|
|
Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec
Number of Grade 4 Toxicities Reported
|
0 events
|
|
Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec
Number of Grade 5 Toxicities Reported
|
0 events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Eight patients completed 8 weeks of imatinib and were considered evaluable for response.
The percentage of patients with 6 months progression-free survival was estimated. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, the appearance of new lesions, or the significant clinical deterioration related to progression of patient's disease.
Outcome measures
| Measure |
Imatinib (Gleevec) Tablets
n=8 Participants
Subjects were administered oral Gleevec tablets, then tumor response was assessed
|
|---|---|
|
6 Month Progression Free Survival Rate
|
27 percentage of patients
Interval 7.0 to 54.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Eight patients completed 8 weeks of imatinib and were considered evaluable for response.
The percentage of patients still alive at 6 months was estimated.
Outcome measures
| Measure |
Imatinib (Gleevec) Tablets
n=8 Participants
Subjects were administered oral Gleevec tablets, then tumor response was assessed
|
|---|---|
|
6 Month Survival Rate
|
46 percentage of patients
Interval 17.0 to 71.0
|
Adverse Events
Imatinib (Gleevec) Tablets
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib (Gleevec) Tablets
n=11 participants at risk
patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
|
|---|---|
|
Nervous system disorders
Neuropathy
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Melena / GI Bleeding
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
Syncope
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Syndrome, Other
|
18.2%
2/11 • Number of events 3
|
|
Infections and infestations
Infection Without Neutropenia
|
9.1%
1/11 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Imatinib (Gleevec) Tablets
n=11 participants at risk
patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
|
|---|---|
|
Investigations
Lymphopenia
|
54.5%
6/11 • Number of events 19
|
|
Blood and lymphatic system disorders
Anemia
|
54.5%
6/11 • Number of events 16
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Weight Loss
|
27.3%
3/11 • Number of events 5
|
|
General disorders
Fatigue
|
63.6%
7/11 • Number of events 18
|
|
Infections and infestations
Infection
|
27.3%
3/11 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
27.3%
3/11 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruising
|
27.3%
3/11 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Dysphasia
|
18.2%
2/11 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Number of events 7
|
|
Gastrointestinal disorders
Melena / GI Bleeding
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
27.3%
3/11 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.5%
5/11 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
45.5%
5/11 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.3%
3/11 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
2/11 • Number of events 2
|
|
Renal and urinary disorders
Urinary Urgency
|
18.2%
2/11 • Number of events 3
|
|
General disorders
Edema
|
63.6%
7/11 • Number of events 14
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
2/11 • Number of events 3
|
|
Investigations
Elevated Creatinine
|
18.2%
2/11 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
4/11 • Number of events 8
|
|
Investigations
Abnormal Aspartate Aminotransferase (AST)
|
36.4%
4/11 • Number of events 11
|
|
Cardiac disorders
Hypertension
|
9.1%
1/11 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Ataxia
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Blurry Vision
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Memory Loss
|
18.2%
2/11 • Number of events 2
|
|
Psychiatric disorders
Mood Change - Anxiety
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Mood Change - Depression
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Alkaline Phosphatase Increased
|
9.1%
1/11 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
9.1%
1/11 • Number of events 2
|
|
Investigations
Creatinine Phosphokinase (CPK)
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Depressed Level of Consciousness
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 6
|
|
General disorders
Fever
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
63.6%
7/11 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.3%
3/11 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.3%
3/11 • Number of events 4
|
|
Renal and urinary disorders
Incontinence
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
Inner Ear / Hearing
|
9.1%
1/11 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Leukopenia
|
36.4%
4/11 • Number of events 16
|
|
Investigations
Lipase
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
36.4%
4/11 • Number of events 7
|
|
General disorders
Pain - Other
|
45.5%
5/11 • Number of events 5
|
|
Investigations
Partial Thromboplastin Time (PTT)
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
9.1%
1/11 • Number of events 2
|
|
General disorders
Rigors / Chills
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Abnormal Alanine Transaminase (ALT)
|
36.4%
4/11 • Number of events 5
|
|
Reproductive system and breast disorders
Sexual / Reproductive Function
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
9.1%
1/11 • Number of events 2
|
|
General disorders
Sweating
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
36.4%
4/11 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
4/11 • Number of events 4
|
Additional Information
Frances Worden, M.D.
University of Michigan Comprehensive Cancer Center
Phone: (734) 615-6633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place