Trial Outcomes & Findings for Sorafenib in Treating Patients With Advanced Malignant Solid Tumors (NCT NCT00810394)
NCT ID: NCT00810394
Last Updated: 2018-01-10
Results Overview
Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
At least 3 months
Results posted on
2018-01-10
Participant Flow
Participant milestones
| Measure |
Sorafenib
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Cycle 2 600mg Twice Daily
|
13
|
|
Overall Study
Cycle 2 400mg Once Daily
|
22
|
|
Overall Study
Cycle 3 800 mg Twice Daily
|
4
|
|
Overall Study
Cycle 3 400mg Twice Daily
|
5
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sorafenib
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Sorafenib in Treating Patients With Advanced Malignant Solid Tumors
Baseline characteristics by cohort
| Measure |
Sorafenib
n=50 Participants
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Age, Continuous
|
61 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At least 3 monthsOverall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.
Outcome measures
| Measure |
Sorafenib
n=50 Participants
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity
|
11 Participants
|
SECONDARY outcome
Timeframe: At least 3 monthsPopulation: Of the 34 patients who were evaluable for treatment response by RECIST, no responses were observed.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 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=34 Participants
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Overall Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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 |
Sorafenib
n=34 Participants
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Time to Disease Progression
|
4.7 months
Interval 4.3 to 6.1
|
Adverse Events
Sorafenib
Serious events: 19 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib
n=50 participants at risk
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Hemorrhage
|
4.0%
2/50 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Up to 2 years
|
|
General disorders
Fever
|
4.0%
2/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
2/50 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/50 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Up to 2 years
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
2.0%
1/50 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Ataxia
|
2.0%
1/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
INR
|
2.0%
1/50 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.0%
1/50 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
4.0%
2/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
2.0%
1/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hand and Foot Syndrome
|
2.0%
1/50 • Up to 2 years
|
Other adverse events
| Measure |
Sorafenib
n=50 participants at risk
Dose Re-Escalation Following a Dose Reduction
Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
10/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.0%
7/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.0%
11/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
3/50 • Up to 2 years
|
|
Cardiac disorders
Hypertension
|
26.0%
13/50 • Up to 2 years
|
|
General disorders
Fever
|
10.0%
5/50 • Up to 2 years
|
|
General disorders
Fatigue
|
34.0%
17/50 • Up to 2 years
|
|
General disorders
Weight Loss
|
14.0%
7/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
5/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hand Foot Skin Reaction
|
32.0%
16/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.0%
3/50 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.0%
14/50 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
4.0%
2/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Edema
|
6.0%
3/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
8.0%
4/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase
|
14.0%
7/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
AST
|
10.0%
5/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Bicarbonate, Serum
|
8.0%
4/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
6.0%
3/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
6.0%
3/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
14.0%
7/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hyponatremia
|
10.0%
5/50 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
18.0%
9/50 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
4.0%
2/50 • Up to 2 years
|
|
Psychiatric disorders
Mood Alteration
|
8.0%
4/50 • Up to 2 years
|
|
General disorders
Pain
|
36.0%
18/50 • Up to 2 years
|
|
General disorders
Voice Changes
|
6.0%
3/50 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place