Trial Outcomes & Findings for Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer (NCT NCT00654238)
NCT ID: NCT00654238
Last Updated: 2019-11-18
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
59 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
Sorafenib
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Sorafenib
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
Overall Study
Screen Failures
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sorafenib
n=55 Participants
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
Age, Continuous
|
63 years
n=55 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=55 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
|
Histology subtype
DIfferentiated
|
44 Participants
n=55 Participants
|
|
Histology subtype
Poorly Differentiated
|
6 Participants
n=55 Participants
|
|
Histology subtype
Medullary
|
3 Participants
n=55 Participants
|
|
Histology subtype
Anaplastic
|
2 Participants
n=55 Participants
|
|
ECOG Performance Status at Baseline
ECOG Performance Status 0
|
29 Participants
n=55 Participants
|
|
ECOG Performance Status at Baseline
ECOG Performance Status 1
|
26 Participants
n=55 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsPopulation: Responses were calculated by total enrolled to each group by histologic subtype.
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 |
Sorafenib
n=55 Participants
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Differentiated · Partial response
|
16 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Differentiated · Stable Disease
|
22 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Poorly Differenitated · Complete Response
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Poorly Differenitated · Partial response
|
2 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Poorly Differenitated · Progressive Disease
|
1 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Poorly Differenitated · Not Evaluable for Response
|
2 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Medullary · Not Evaluable for Response
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Anaplastic · Complete Response
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Differentiated · Complete Response
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Differentiated · Progressive Disease
|
1 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Differentiated · Not Evaluable for Response
|
5 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Poorly Differenitated · Stable Disease
|
1 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Medullary · Complete Response
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Medullary · Partial response
|
1 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Medullary · Stable Disease
|
2 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Medullary · Progressive Disease
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Anaplastic · Partial response
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Anaplastic · Stable Disease
|
0 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Anaplastic · Progressive Disease
|
1 Participants
|
|
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Anaplastic · Not Evaluable for Response
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsPopulation: Of the 59 patients that were consented, four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review. Therefore the total number of patients analyzed going forward was 55.
This is the result of the Kaplan Meier analysis of all patients treated with sorafenib
Outcome measures
| Measure |
Sorafenib
n=55 Participants
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib).
|
77 weeks
Interval 60.0 to 96.0
|
Adverse Events
Sorafenib
Serious events: 4 serious events
Other events: 43 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Sorafenib
n=55 participants at risk
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
Blood and lymphatic system disorders
Deep Vein Thhrombosis
|
3.6%
2/55 • Number of events 2 • 5 Years
|
|
Nervous system disorders
Cerebral Vascular Accident/Stroke
|
3.6%
2/55 • Number of events 2 • 5 Years
|
Other adverse events
| Measure |
Sorafenib
n=55 participants at risk
This is a single arm study.
sorafenib: 400mg PO BID daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hand Foot Skin Reaction
|
78.2%
43/55 • Number of events 43 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
74.5%
41/55 • Number of events 41 • 5 Years
|
|
Gastrointestinal disorders
Diarrhea
|
52.7%
29/55 • Number of events 29 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.5%
25/55 • Number of events 25 • 5 Years
|
|
Gastrointestinal disorders
Stomatitis/Mucositis
|
32.7%
18/55 • Number of events 18 • 5 Years
|
|
General disorders
Fatigue
|
27.3%
15/55 • Number of events 15 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
11/55 • Number of events 11 • 5 Years
|
|
Gastrointestinal disorders
GI Discomfort
|
16.4%
9/55 • Number of events 9 • 5 Years
|
|
Vascular disorders
Hypertension
|
14.5%
8/55 • Number of events 8 • 5 Years
|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma of the Skin
|
14.5%
8/55 • Number of events 8 • 5 Years
|
|
Metabolism and nutrition disorders
Anorexia and Weight Loss
|
12.7%
7/55 • Number of events 7 • 5 Years
|
|
Gastrointestinal disorders
Hepatic Lab Abnormalities
|
1.8%
1/55 • Number of events 1 • 5 Years
|
Additional Information
Dr. Marcia Brose
Abramson Cancer Center at the University of Pennsylvania
Phone: 215-746-6344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place