Trial Outcomes & Findings for Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer (NCT NCT01471353)
NCT ID: NCT01471353
Last Updated: 2020-07-23
Results Overview
Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. 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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
2 years
Results posted on
2020-07-23
Participant Flow
43 Patients were consented and enrolled; however, only 42 were dosed. The one patient that was not dosed was removed due to progression of disease prior to treatment initiation.
Participant milestones
| Measure |
Sorafenib Plus Capecitabine (SorCape)
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sorafenib Plus Capecitabine (SorCape)
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Overall Study
remain on study
|
3
|
Baseline Characteristics
Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 Participants
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
|
Age, Continuous
|
57 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDetermine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. 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
Outcome measures
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 Participants
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Sorafenib Activity
|
123 days
Interval 62.0 to 132.0
|
SECONDARY outcome
Timeframe: 5 yearsEvaluate overall survival after treatment.
Outcome measures
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 Participants
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Overall Survival
|
261 days
Interval 132.0 to 370.0
|
SECONDARY outcome
Timeframe: 3 monthsThis is the percentage of subjects that achieved either a complete response or a partial response per RECIST 1.1 criteria
Outcome measures
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 Participants
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Response Rate
|
2.38 percentage of participants
Interval 0.06 to 12.57
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: No data are available for this outcome measure since only 1 participant achieved a partial or complete response.
This is the median response duration (median time from date of a complete or partial response to date of disease progression per RECIST 1.1 criteria) and includes only subjects that achieved either a complete or partial response to treatment per RECIST 1.1 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsEvaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system - a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions.
Outcome measures
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 Participants
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Toxicity (Percentage of Subjects That Experienced an Adverse Event)
Adverse Events - Any Grade
|
100 percentage of participants
|
|
Toxicity (Percentage of Subjects That Experienced an Adverse Event)
Adverse Events - Grade 3
|
74 percentage of participants
|
|
Toxicity (Percentage of Subjects That Experienced an Adverse Event)
Adverse Events - Grade 4
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected.
Exploratory tissue analysis in patients receiving sorafenib plus capecitabine
Outcome measures
Outcome data not reported
Adverse Events
Sorafenib Plus Capecitabine (SorCape)
Serious events: 13 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 participants at risk
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Spleen Disorder
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Sinus Tachycardia
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Colonic Obstruction
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Bowel Perforation
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1
|
|
General disorders
General Disorders and Administration Site Conditions - Other, Anasarca
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
4.8%
2/42 • Number of events 3
|
|
General disorders
Pain
|
2.4%
1/42 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other, Cirrhosis
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Creatinine Increased
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Hyponatremia
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Sorafenib Plus Capecitabine (SorCape)
n=42 participants at risk
Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
21.4%
9/42 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Anorectal Infection
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
40.5%
17/42 • Number of events 19
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/42 • Number of events 2
|
|
Gastrointestinal disorders
Bloating
|
2.4%
1/42 • Number of events 3
|
|
Eye disorders
Blurred Vision
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Cardiac Disorders - Other, Ventricular Bigeminy
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
14.3%
6/42 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Number of events 5
|
|
Investigations
Creatinine Increasted
|
2.4%
1/42 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
3/42 • Number of events 4
|
|
Psychiatric disorders
Delirium
|
4.8%
2/42 • Number of events 2
|
|
Psychiatric disorders
Delusions
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
38.1%
16/42 • Number of events 30
|
|
Eye disorders
Dry Eye
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
4/42 • Number of events 4
|
|
Gastrointestinal disorders
Enterocolitis
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Fatigue
|
59.5%
25/42 • Number of events 36
|
|
General disorders
Fever
|
2.4%
1/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.4%
1/42 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
2/42 • Number of events 2
|
|
General disorders
Flu-Like Symptoms
|
9.5%
4/42 • Number of events 4
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Gastric Bezoar
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
2/42 • Number of events 3
|
|
Vascular disorders
Hot Flashes
|
2.4%
1/42 • Number of events 2
|
|
Vascular disorders
Hypertension
|
21.4%
9/42 • Number of events 13
|
|
Investigations
Hypokalemia
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Hyponatremia
|
4.8%
2/42 • Number of events 2
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infections and Infestations - Other, Cold Symptoms
|
4.8%
2/42 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Localized Edema
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Malaise
|
4.8%
2/42 • Number of events 2
|
|
Infections and infestations
Mucosal Infection
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis Oral
|
16.7%
7/42 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other, Muscle Cramps
|
4.8%
2/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other, Wrist Sprain
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
40.5%
17/42 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
4.8%
2/42 • Number of events 8
|
|
General disorders
Pain
|
9.5%
4/42 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
85.7%
36/42 • Number of events 126
|
|
Infections and infestations
Pelvic Infection
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.1%
3/42 • Number of events 3
|
|
Psychiatric disorders
Personality Change
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
7.1%
3/42 • Number of events 3
|
|
Investigations
Platelet Count Decreased
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Presyncope
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.4%
1/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
9.5%
4/42 • Number of events 4
|
|
Renal and urinary disorders
Renal Calculi
|
2.4%
1/42 • Number of events 2
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other, Brittle Nails
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Splenic Infection
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Syncope
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
Thromboembolic Event
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection
|
7.1%
3/42 • Number of events 3
|
|
Infections and infestations
Urinary Tract Infection
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
Urine Discoloration
|
2.4%
1/42 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
11/42 • Number of events 12
|
|
Infections and infestations
Weight Loss
|
21.4%
9/42 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place