Trial Outcomes & Findings for Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer (NCT NCT00118248)
NCT ID: NCT00118248
Last Updated: 2017-02-15
Results Overview
The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval. 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. Patients that are not classified as having a progression are termed progression-free.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
1 year
Results posted on
2017-02-15
Participant Flow
From February 2005 thru April 2009, 41 participants were accrued to the this study. The study was closed to enrollment in July, 2009 due to a slow accrual rate.
From February 2005 thru February 2009, 17 participants were accrued to the Advanced Medullary Thyroid Carcinoma group. From February 2008 thru April 2009, 24 participants were accrued to the Differentiated Thyroid Carcinoma group.
Participant milestones
| Measure |
Advanced Medullary Thyroid Carcinoma Group
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
24
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Advanced Medullary Thyroid Carcinoma Group
n=17 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
n=24 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
61 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
24 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All patients were evaluable for this endpoint in this group.
The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval. 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. Patients that are not classified as having a progression are termed progression-free.
Outcome measures
| Measure |
Advanced Medullary Thyroid Carcinoma Group
n=17 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
n=24 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)
|
5.9 percentage of participants
Interval 0.3 to 25.0
|
12.5 percentage of participants
Interval 3.5 to 29.2
|
SECONDARY outcome
Timeframe: Baseline, every 3 courses, and at the end of treatment studyPopulation: All participants were evaluated for response.
The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0. Complete Response (CR): Disappearance of all lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Advanced Medullary Thyroid Carcinoma Group
n=17 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
n=24 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Overall Response
Partial Response (PR)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Every 3 months for up to 3 yearsPopulation: All participants were evaluable for this endpoint.
Defined as the time from registration to the date of progression or death due to any cause. 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. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Advanced Medullary Thyroid Carcinoma Group
n=17 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
n=24 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival
|
6.4 months
Interval 2.7 to 17.2
|
4.1 months
Interval 2.2 to 8.7
|
SECONDARY outcome
Timeframe: Every 3 months until progression, and then every 6 months up to 3 yearsPopulation: All patients were evaluable for this endpoint.
Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Advanced Medullary Thyroid Carcinoma Group
n=17 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
n=24 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
2.1 years
Interval 0.67 to 3.1
|
1.5 years
Interval 0.73 to 3.5
|
SECONDARY outcome
Timeframe: Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)Population: All participants were evaluable for this endpoint.
Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Advanced Medullary Thyroid Carcinoma Group
n=17 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Differentiated Thyroid Carcinoma
n=24 Participants
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Toxicity
Grade 5
|
1 participants
|
0 participants
|
|
Toxicity
Grade 3 or Higher
|
4 participants
|
9 participants
|
|
Toxicity
Grade 4 or Higher
|
3 participants
|
0 participants
|
Adverse Events
All Patients
Serious events: 13 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=41 participants at risk
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • Number of events 2
|
|
General disorders
Edema limbs
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Fever
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Infection
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Platelet count decreased
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.4%
1/41 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
All Patients
n=41 participants at risk
Patients receive 220 mg/m\^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
58.5%
24/41 • Number of events 104
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.9%
2/41 • Number of events 3
|
|
Cardiac disorders
Cardiac disorder
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.4%
1/41 • Number of events 11
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/41 • Number of events 12
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/41 • Number of events 4
|
|
Eye disorders
Photophobia
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • Number of events 13
|
|
Gastrointestinal disorders
Diarrhea
|
61.0%
25/41 • Number of events 63
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
14.6%
6/41 • Number of events 17
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
53.7%
22/41 • Number of events 93
|
|
Gastrointestinal disorders
Tooth disorder
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
11/41 • Number of events 23
|
|
General disorders
Chest pain
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Chills
|
9.8%
4/41 • Number of events 6
|
|
General disorders
Edema limbs
|
9.8%
4/41 • Number of events 15
|
|
General disorders
Fatigue
|
63.4%
26/41 • Number of events 72
|
|
General disorders
Fever
|
7.3%
3/41 • Number of events 4
|
|
General disorders
Localized edema
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Pain
|
7.3%
3/41 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Infection
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • Number of events 5
|
|
Injury, poisoning and procedural complications
Bruising
|
4.9%
2/41 • Number of events 6
|
|
Investigations
Alanine aminotransferase increased
|
51.2%
21/41 • Number of events 74
|
|
Investigations
Alkaline phosphatase increased
|
46.3%
19/41 • Number of events 71
|
|
Investigations
Aspartate aminotransferase increased
|
43.9%
18/41 • Number of events 64
|
|
Investigations
Blood bilirubin increased
|
22.0%
9/41 • Number of events 41
|
|
Investigations
Creatinine increased
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.6%
6/41 • Number of events 17
|
|
Investigations
Leukocyte count decreased
|
22.0%
9/41 • Number of events 42
|
|
Investigations
Lymphocyte count decreased
|
24.4%
10/41 • Number of events 26
|
|
Investigations
Neutrophil count decreased
|
12.2%
5/41 • Number of events 11
|
|
Investigations
Platelet count decreased
|
7.3%
3/41 • Number of events 5
|
|
Investigations
Weight loss
|
9.8%
4/41 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
7/41 • Number of events 12
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
14.6%
6/41 • Number of events 9
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
4.9%
2/41 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
9.8%
4/41 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
9.8%
4/41 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.9%
2/41 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
12.2%
5/41 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.9%
2/41 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
4.9%
2/41 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
4/41 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.2%
5/41 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
5/41 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.2%
5/41 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.5%
8/41 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.2%
5/41 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Number of events 22
|
|
Nervous system disorders
Dysgeusia
|
12.2%
5/41 • Number of events 8
|
|
Nervous system disorders
Headache
|
14.6%
6/41 • Number of events 11
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/41 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.2%
5/41 • Number of events 15
|
|
Psychiatric disorders
Anxiety
|
14.6%
6/41 • Number of events 18
|
|
Psychiatric disorders
Depression
|
14.6%
6/41 • Number of events 17
|
|
Psychiatric disorders
Insomnia
|
14.6%
6/41 • Number of events 19
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/41 • Number of events 1
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.9%
2/41 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.3%
12/41 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.6%
15/41 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.2%
5/41 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.2%
5/41 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Body odor
|
17.1%
7/41 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/41 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.9%
2/41 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Sweating
|
9.8%
4/41 • Number of events 10
|
|
Vascular disorders
Flushing
|
4.9%
2/41 • Number of events 3
|
|
Vascular disorders
Hot flashes
|
2.4%
1/41 • Number of events 3
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60