Trial Outcomes & Findings for Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer (NCT NCT01025453)
NCT ID: NCT01025453
Last Updated: 2018-08-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
2 years
Results posted on
2018-08-15
Participant Flow
Participant milestones
| Measure |
Pts Getting Temsirolimus and Sorafenib
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=37 Participants
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 7 participants were not evaluable because they came off treatment before the first radiographic scan for reasons other than progression of disease, including but not limited to excessive toxicity (n=1), withdrawal of consent (n=3), and seeing other treatment (n=1).
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
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=30 Participants
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
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|---|---|
|
Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.
Partial Response
|
8 Participants
|
|
Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.
Stable Disease
|
21 Participants
|
|
Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.
Disease Progression
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: The analysis separated the participants into 2 groups (number of patients with BRAF V600E Mutation and number of patients without BRAF V600E Mutation)
Outcome measures
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=36 Participants
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Duration of Study Treatment for Participants With and Without BRAF Mutations
Pts with BRAF V600E Mutation
|
5.2 months
Interval 0.7 to 63.0
|
|
Duration of Study Treatment for Participants With and Without BRAF Mutations
Pts w/o BRAF V600E Mutation
|
6.7 months
Interval 0.5 to 25.6
|
SECONDARY outcome
Timeframe: 1 yearProgression 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
Outcome measures
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=37 Participants
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.
|
30.5 percentage of patients
|
SECONDARY outcome
Timeframe: 3 yearsParticipant toxicities evaluated by CTCAE version 4.0
Outcome measures
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=37 Participants
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.
|
37 Participants
|
Adverse Events
Pts Getting Temsirolimus and Sorafenib
Serious events: 23 serious events
Other events: 37 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=37 participants at risk
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
8.1%
3/37 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
1/37 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
10.8%
4/37 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.7%
1/37 • 2 years
|
|
Infections and infestations
Appendicitis
|
2.7%
1/37 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.7%
1/37 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
3/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
13.5%
5/37 • 2 years
|
|
Infections and infestations
Catheter related infection
|
5.4%
2/37 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Colonic perforation
|
5.4%
2/37 • 2 years
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • 2 years
|
|
General disorders
Cough
|
2.7%
1/37 • 2 years
|
|
Investigations
Creatinine increased
|
2.7%
1/37 • 2 years
|
|
General disorders
Death NOS
|
5.4%
2/37 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
3/37 • 2 years
|
|
Psychiatric disorders
Delirium
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
8.1%
3/37 • 2 years
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • 2 years
|
|
Nervous system disorders
Dysarthria
|
5.4%
2/37 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.4%
2/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.2%
6/37 • 2 years
|
|
General disorders
Edema limbs
|
5.4%
2/37 • 2 years
|
|
General disorders
Fatigue
|
5.4%
2/37 • 2 years
|
|
General disorders
Fever
|
8.1%
3/37 • 2 years
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • 2 years
|
|
Cardiac disorders
Heart failure
|
2.7%
1/37 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.4%
2/37 • 2 years
|
|
Vascular disorders
Hypertension
|
8.1%
3/37 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
1/37 • 2 years
|
|
Vascular disorders
Hypotension
|
8.1%
3/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
5.4%
2/37 • 2 years
|
|
Infections and infestations
Lung infection
|
5.4%
2/37 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal hemorrhage
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
10.8%
4/37 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
1/37 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
8.1%
3/37 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
2.7%
1/37 • 2 years
|
|
General disorders
Pain
|
2.7%
1/37 • 2 years
|
|
Nervous system disorders
Paresthesia
|
2.7%
1/37 • 2 years
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.4%
2/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
1/37 • 2 years
|
|
Nervous system disorders
Seizure
|
2.7%
1/37 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
2/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
1/37 • 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.7%
1/37 • 2 years
|
|
General disorders
Sudden death NOS
|
2.7%
1/37 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
5.4%
2/37 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
5.4%
2/37 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • 2 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
18.9%
7/37 • 2 years
|
|
Infections and infestations
Wound infection
|
2.7%
1/37 • 2 years
|
Other adverse events
| Measure |
Pts Getting Temsirolimus and Sorafenib
n=37 participants at risk
We propose a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell). A maximum of 36 subjects will be evaluated during the study. Restaging scans, with evaluation of response, will be done every 2 cycles (8 weeks of treatment). Treatment will continue until clinical disease progression, unacceptable toxicity, treatment delay \> 4 weeks, or at the discretion of the treating physician or patient.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
56.8%
21/37 • 2 years
|
|
Investigations
Platelet count decreased
|
29.7%
11/37 • 2 years
|
|
General disorders
Fatigue
|
37.8%
14/37 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.2%
6/37 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
29.7%
11/37 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
21.6%
8/37 • 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
16.2%
6/37 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
8.1%
3/37 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
32.4%
12/37 • 2 years
|
|
Vascular disorders
Hypertension
|
40.5%
15/37 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
18.9%
7/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.2%
6/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
16.2%
6/37 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
18.9%
7/37 • 2 years
|
|
Investigations
Weight loss
|
18.9%
7/37 • 2 years
|
|
Investigations
White blood cell decreased
|
13.5%
5/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.5%
5/37 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
8.1%
3/37 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
13.5%
5/37 • 2 years
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
3/37 • 2 years
|
|
General disorders
Edema limbs
|
10.8%
4/37 • 2 years
|
|
General disorders
Fever
|
5.4%
2/37 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.1%
3/37 • 2 years
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
2/37 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
5.4%
2/37 • 2 years
|
|
Investigations
Creatinine increased
|
5.4%
2/37 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
5.4%
2/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.4%
2/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.1%
3/37 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
2/37 • 2 years
|
|
Gastrointestinal disorders
Colonic perforation
|
5.4%
2/37 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37 • 2 years
|
Additional Information
Dr. Eric Sherman, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place