Trial Outcomes & Findings for Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery (NCT NCT01900002)
NCT ID: NCT01900002
Last Updated: 2021-12-30
Results Overview
Will be monitored using the method of Thall et al. Kaplan-Meier method will be used to estimate median progression free survival (PFS) and the 95% confidence interval. Log rank test, univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors for progression free survival (PFS).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From the start of therapy until failure to disease progression or death, assessed up to 4 years
Results posted on
2021-12-30
Participant Flow
September 2013 - December 2020. All participants were enrolled in MD Anderson
Participant milestones
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
ineligible for Y-90
|
4
|
Baseline Characteristics
Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
n=34 Participants
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
68.2 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From the start of therapy until failure to disease progression or death, assessed up to 4 yearsWill be monitored using the method of Thall et al. Kaplan-Meier method will be used to estimate median progression free survival (PFS) and the 95% confidence interval. Log rank test, univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors for progression free survival (PFS).
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
n=34 Participants
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
10.32 months
Interval 5.78 to 14.36
|
SECONDARY outcome
Timeframe: Up to 4 years95% credible interval will be estimated. This will be analyzed using Kaplan-Meier method, Log rank test and Cox proportional hazards regression modeling.
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
n=34 Participants
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Time to Progression (TTP)
|
10.38 months
Interval 5.78 to 18.76
|
SECONDARY outcome
Timeframe: Up to 4 yearsTo evaluate the safety of the combination of sorafenib (sorafenib tosylate) and Yttrium-90; adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 \[NCI-CTAE v 4.0\]) .
Outcome measures
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
n=34 Participants
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Fatigue
|
3 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Diarrhea
|
2 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Nausea
|
1 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Vomiting
|
2 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Hypertension
|
4 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Thrombocytopenia
|
1 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Hyperbilirubinemia
|
1 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Proteinuria
|
1 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
ALT increase
|
1 Participants
|
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
AST increase
|
1 Participants
|
Adverse Events
Treatment (Sorafenib Tosylate, TheraSphere)
Serious events: 11 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
n=34 participants at risk
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Nervous system disorders
Dizziness
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Hyponatremia
|
8.8%
3/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Hepatic Hemorrhage
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Renal and urinary disorders
Urinary Retention
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Vascular disorders
Hypertenstion
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Renal and urinary disorders
Acute Renal Failure
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Hypophosphatemia
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Rectal Bleed
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
General disorders
Weakness
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/34 • adverse events were collected up to 4 years
|
Other adverse events
| Measure |
Treatment (Sorafenib Tosylate, TheraSphere)
n=34 participants at risk
Patients receive sorafenib tosylate PO BID. After 4 weeks, patients receive yttrium Y 90 glass microspheres IA. Courses of sorafenib tosylate repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Fatigue
|
8.8%
3/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Weight Loss
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Skin and subcutaneous tissue disorders
Palmar-Planta Erythrodysesthesia
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Vascular disorders
Hypertension
|
11.8%
4/34 • adverse events were collected up to 4 years
|
|
Investigations
Thrombocytopenia
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Hyperbilirubinemia
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Proteinuria
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Hyponatremia
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
Hypophosphatemia
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Gastrointestinal disorders
Mucositis
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Nervous system disorders
Encephalopathy
|
2.9%
1/34 • adverse events were collected up to 4 years
|
|
Investigations
ALT increase
|
5.9%
2/34 • adverse events were collected up to 4 years
|
|
Investigations
AST increase
|
11.8%
4/34 • adverse events were collected up to 4 years
|
Additional Information
Dr. Ahmed Kaseb, MD, Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place