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Trial record 3 of 46 for:    SIR-Spheres

Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02195011
Recruitment Status : Completed
First Posted : July 21, 2014
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Sirtex Medical
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Device: SIR-Spheres
Drug: Regorafenib
Enrollment 26
Recruitment Details Between July 2014 and February 2017, 26 patients with metastatic colorectal cancer (mCRC) with liver metastases were enrolled. The study was closed early due to slow enrollment.
Pre-assignment Details  
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Hide Arm/Group Description

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Period Title: Overall Study
Started 25 1
Completed 0 0
Not Completed 25 1
Reason Not Completed
Adverse Event             4             0
Progressive Disease             18             1
Withdrawal by Subject             3             0
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib Total
Hide Arm/Group Description

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Total of all reporting groups
Overall Number of Baseline Participants 25 1 26
Hide Baseline Analysis Population Description
All patients who received at least one dose of treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 1 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  68.0%
1
 100.0%
18
  69.2%
>=65 years
8
  32.0%
0
   0.0%
8
  30.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 1 participants 26 participants
56
(44 to 79)
64
(64 to 64)
56
(44 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 1 participants 26 participants
Female
13
  52.0%
0
   0.0%
13
  50.0%
Male
12
  48.0%
1
 100.0%
13
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 1 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
0
   0.0%
3
  11.5%
White
22
  88.0%
1
 100.0%
23
  88.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 1 participants 26 participants
25
 100.0%
1
 100.0%
26
 100.0%
1.Primary Outcome
Title The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety
Hide Description A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.
Time Frame up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who receive at least one dose of treatment.
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Hide Arm/Group Description:

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Overall Number of Participants Analyzed 25 1
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
1
 100.0%
2.Secondary Outcome
Title Number of Patients With an Objective Response (CR or PR)
Hide Description Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.
Time Frame At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients who have received study treatment.
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Hide Arm/Group Description:

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Overall Number of Participants Analyzed 25 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
0
   0.0%
3.Secondary Outcome
Title Median Progression-Free Survival
Hide Description Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.
Time Frame At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients who received treatment.
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Hide Arm/Group Description:

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Overall Number of Participants Analyzed 25 1
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(2.6 to 9.7)
NA [1] 
(NA to NA)
[1]
Not reached at this time
4.Secondary Outcome
Title Median Overall Survival
Hide Description Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive.
Time Frame up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients who received treatment.
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Hide Arm/Group Description:

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Overall Number of Participants Analyzed 25 1
Median (95% Confidence Interval)
Unit of Measure: Months
12.1
(6.0 to 16.4)
NA [1] 
(NA to NA)
[1]
Not reached at this time.
Time Frame Up to 15 months.
Adverse Event Reporting Description All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
 
Arm/Group Title Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Hide Arm/Group Description

Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.

Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.

Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle

All-Cause Mortality
Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   16/25 (64.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   10/25 (40.00%)   0/1 (0.00%) 
Cardiac disorders     
Myocardial infarction * 1  1/25 (4.00%)  0/1 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  1/25 (4.00%)  0/1 (0.00%) 
Abdominal pain * 1  2/25 (8.00%)  0/1 (0.00%) 
Diarrhoea * 1  1/25 (4.00%)  0/1 (0.00%) 
Intestinal perforation * 1  1/25 (4.00%)  0/1 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  1/25 (4.00%)  0/1 (0.00%) 
Portal hypertension * 1  1/25 (4.00%)  0/1 (0.00%) 
Infections and infestations     
Sepsis * 1  2/25 (8.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia * 1  1/25 (4.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/25 (4.00%)  0/1 (0.00%) 
Muscle haemorrhage * 1  1/25 (4.00%)  0/1 (0.00%) 
Psychiatric disorders     
Mental status changes * 1  1/25 (4.00%)  0/1 (0.00%) 
Reproductive system and breast disorders     
Pelvic pain * 1  1/25 (4.00%)  0/1 (0.00%) 
Vascular disorders     
Hypertensive crisis * 1  1/25 (4.00%)  0/1 (0.00%) 
1
Term from vocabulary, CTCAE (Unspecified)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Regorafenib/SIR-Spheres/Regorafenib Cohort 2: SIR-Spheres/Regorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   25/25 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders     
ANAEMIA * 1  6/25 (24.00%)  0/1 (0.00%) 
NEUTROPENIA * 1  2/25 (8.00%)  0/1 (0.00%) 
THROMBOCYTOPENIA * 1  4/25 (16.00%)  0/1 (0.00%) 
Cardiac disorders     
MYOCARDIAL INFARCTION * 1  1/25 (4.00%)  0/1 (0.00%) 
PERICARDIAL EFFUSION * 1  1/25 (4.00%)  0/1 (0.00%) 
Ear and labyrinth disorders     
MOTION SICKNESS * 1  1/25 (4.00%)  0/1 (0.00%) 
Eye disorders     
VISION BLURRED * 1  1/25 (4.00%)  0/1 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION * 1  1/25 (4.00%)  0/1 (0.00%) 
ABDOMINAL PAIN * 1  11/25 (44.00%)  1/1 (100.00%) 
ASCITES * 1  1/25 (4.00%)  0/1 (0.00%) 
CONSTIPATION * 1  9/25 (36.00%)  1/1 (100.00%) 
DIARRHOEA * 1  10/25 (40.00%)  0/1 (0.00%) 
DRY MOUTH * 1  3/25 (12.00%)  0/1 (0.00%) 
DUODENAL ULCER * 1  1/25 (4.00%)  0/1 (0.00%) 
DYSPEPSIA * 1  1/25 (4.00%)  0/1 (0.00%) 
DYSPHAGIA * 1  1/25 (4.00%)  0/1 (0.00%) 
EPIGASTRIC DISCOMFORT * 1  1/25 (4.00%)  0/1 (0.00%) 
FAECES DISCOLOURED * 1  1/25 (4.00%)  0/1 (0.00%) 
GASTROINTESTINAL PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  3/25 (12.00%)  0/1 (0.00%) 
GINGIVAL BLEEDING * 1  1/25 (4.00%)  0/1 (0.00%) 
HAEMORRHOIDS * 1  1/25 (4.00%)  0/1 (0.00%) 
HIATUS HERNIA * 1  1/25 (4.00%)  0/1 (0.00%) 
IMPAIRED GASTRIC EMPTYING * 1  1/25 (4.00%)  0/1 (0.00%) 
INTESTINAL PERFORATION * 1  1/25 (4.00%)  0/1 (0.00%) 
NAUSEA * 1  11/25 (44.00%)  1/1 (100.00%) 
OESOPHAGITIS * 1  1/25 (4.00%)  0/1 (0.00%) 
ORAL PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
SENSITIVITY OF TEETH * 1  1/25 (4.00%)  0/1 (0.00%) 
STOMATITIS * 1  3/25 (12.00%)  0/1 (0.00%) 
VOMITING * 1  6/25 (24.00%)  1/1 (100.00%) 
General disorders     
ASTHENIA * 1  4/25 (16.00%)  0/1 (0.00%) 
CHILLS * 1  3/25 (12.00%)  0/1 (0.00%) 
FATIGUE * 1  18/25 (72.00%)  1/1 (100.00%) 
HERNIA * 1  1/25 (4.00%)  0/1 (0.00%) 
HERNIA PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
INFLUENZA LIKE ILLNESS * 1  1/25 (4.00%)  0/1 (0.00%) 
MALAISE * 1  0/25 (0.00%)  1/1 (100.00%) 
MUCOSAL INFLAMMATION * 1  5/25 (20.00%)  0/1 (0.00%) 
OEDEMA PERIPHERAL * 1  2/25 (8.00%)  0/1 (0.00%) 
PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
PYREXIA * 1  4/25 (16.00%)  0/1 (0.00%) 
SWELLING * 1  1/25 (4.00%)  0/1 (0.00%) 
Hepatobiliary disorders     
CHOLANGITIS * 1  1/25 (4.00%)  0/1 (0.00%) 
CHOLECYSTITIS ACUTE * 1  1/25 (4.00%)  0/1 (0.00%) 
HEPATIC CIRRHOSIS * 1  1/25 (4.00%)  0/1 (0.00%) 
HEPATIC FAILURE * 1  1/25 (4.00%)  0/1 (0.00%) 
HEPATOTOXICITY * 1  1/25 (4.00%)  0/1 (0.00%) 
HYPERBILIRUBINAEMIA * 1  1/25 (4.00%)  0/1 (0.00%) 
NON-ALCOHOLIC STEATOHEPATITIS * 1  1/25 (4.00%)  0/1 (0.00%) 
PORTAL HYPERTENSION * 1  1/25 (4.00%)  0/1 (0.00%) 
Immune system disorders     
HYPERSENSITIVITY * 1  1/25 (4.00%)  0/1 (0.00%) 
SEASONAL ALLERGY * 1  1/25 (4.00%)  0/1 (0.00%) 
Infections and infestations     
CANDIDA INFECTION * 1  1/25 (4.00%)  0/1 (0.00%) 
HERPES ZOSTER * 1  1/25 (4.00%)  0/1 (0.00%) 
ORAL CANDIDIASIS * 1  1/25 (4.00%)  0/1 (0.00%) 
PHARYNGITIS * 1  1/25 (4.00%)  0/1 (0.00%) 
POSTOPERATIVE WOUND INFECTION * 1  1/25 (4.00%)  0/1 (0.00%) 
SEPSIS * 1  2/25 (8.00%)  0/1 (0.00%) 
SKIN CANDIDA * 1  1/25 (4.00%)  0/1 (0.00%) 
URINARY TRACT INFECTION * 1  4/25 (16.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications     
PROCEDURAL PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
STOMA SITE IRRITATION * 1  1/25 (4.00%)  0/1 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED * 1  3/25 (12.00%)  1/1 (100.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  6/25 (24.00%)  1/1 (100.00%) 
BLOOD ALBUMIN DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD ALKALINE PHOSPHATASE INCREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD BILIRUBIN DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD BILIRUBIN INCREASED * 1  7/25 (28.00%)  0/1 (0.00%) 
BLOOD CALCIUM DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD CHLORIDE DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD CREATININE INCREASED * 1  2/25 (8.00%)  0/1 (0.00%) 
BLOOD GLUCOSE INCREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD LACTATE DEHYDROGENASE INCREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD PHOSPHORUS DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD PRESSURE INCREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
BLOOD SODIUM DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
CARCINOEMBRYONIC ANTIGEN INCREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
HAEMOGLOBIN DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
LYMPHOCYTE COUNT DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
PARACENTESIS * 1  1/25 (4.00%)  0/1 (0.00%) 
PLATELET COUNT DECREASED * 1  2/25 (8.00%)  0/1 (0.00%) 
PLATELET COUNT INCREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
PROTEIN TOTAL DECREASED * 1  1/25 (4.00%)  0/1 (0.00%) 
WEIGHT DECREASED * 1  3/25 (12.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE * 1  12/25 (48.00%)  1/1 (100.00%) 
DEHYDRATION * 1  3/25 (12.00%)  0/1 (0.00%) 
FAILURE TO THRIVE * 1  2/25 (8.00%)  0/1 (0.00%) 
HYPERKALAEMIA * 1  1/25 (4.00%)  0/1 (0.00%) 
HYPOALBUMINAEMIA * 1  1/25 (4.00%)  0/1 (0.00%) 
HYPOGLYCAEMIA * 1  1/25 (4.00%)  0/1 (0.00%) 
HYPOKALAEMIA * 1  3/25 (12.00%)  0/1 (0.00%) 
HYPONATRAEMIA * 1  5/25 (20.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA * 1  6/25 (24.00%)  0/1 (0.00%) 
BACK PAIN * 1  4/25 (16.00%)  0/1 (0.00%) 
FLANK PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
GROIN PAIN * 1  0/25 (0.00%)  1/1 (100.00%) 
JOINT SWELLING * 1  1/25 (4.00%)  0/1 (0.00%) 
MUSCLE HAEMORRHAGE * 1  1/25 (4.00%)  0/1 (0.00%) 
MUSCLE SPASMS * 1  5/25 (20.00%)  0/1 (0.00%) 
MUSCULAR WEAKNESS * 1  1/25 (4.00%)  0/1 (0.00%) 
MUSCULOSKELETAL DISCOMFORT * 1  1/25 (4.00%)  0/1 (0.00%) 
MYALGIA * 1  4/25 (16.00%)  0/1 (0.00%) 
NECK PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
PAIN IN EXTREMITY * 1  6/25 (24.00%)  0/1 (0.00%) 
RHEUMATOID ARTHRITIS * 1  1/25 (4.00%)  0/1 (0.00%) 
Nervous system disorders     
BALANCE DISORDER * 1  1/25 (4.00%)  0/1 (0.00%) 
DYSGEUSIA * 1  1/25 (4.00%)  0/1 (0.00%) 
HEADACHE * 1  5/25 (20.00%)  0/1 (0.00%) 
HYPOAESTHESIA * 1  1/25 (4.00%)  0/1 (0.00%) 
MIGRAINE * 1  1/25 (4.00%)  0/1 (0.00%) 
NEUROPATHY PERIPHERAL * 1  2/25 (8.00%)  0/1 (0.00%) 
SEIZURE * 1  1/25 (4.00%)  0/1 (0.00%) 
TREMOR * 1  3/25 (12.00%)  0/1 (0.00%) 
Psychiatric disorders     
ABNORMAL DREAMS * 1  1/25 (4.00%)  0/1 (0.00%) 
ANXIETY * 1  1/25 (4.00%)  0/1 (0.00%) 
CONFUSIONAL STATE * 1  1/25 (4.00%)  0/1 (0.00%) 
DEPRESSION * 1  2/25 (8.00%)  0/1 (0.00%) 
INSOMNIA * 1  1/25 (4.00%)  0/1 (0.00%) 
MENTAL STATUS CHANGES * 1  1/25 (4.00%)  0/1 (0.00%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY * 1  1/25 (4.00%)  0/1 (0.00%) 
DYSURIA * 1  1/25 (4.00%)  0/1 (0.00%) 
MICTURITION URGENCY * 1  1/25 (4.00%)  0/1 (0.00%) 
Reproductive system and breast disorders     
BREAST TENDERNESS * 1  1/25 (4.00%)  0/1 (0.00%) 
PELVIC PAIN * 1  1/25 (4.00%)  0/1 (0.00%) 
VAGINAL HAEMORRHAGE * 1  1/25 (4.00%)  0/1 (0.00%) 
VULVA CYST * 1  1/25 (4.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ATELECTASIS * 1  1/25 (4.00%)  0/1 (0.00%) 
COUGH * 1  1/25 (4.00%)  0/1 (0.00%) 
DYSPHONIA * 1  6/25 (24.00%)  0/1 (0.00%) 
DYSPNOEA * 1  4/25 (16.00%)  0/1 (0.00%) 
DYSPNOEA EXERTIONAL * 1  1/25 (4.00%)  0/1 (0.00%) 
HICCUPS * 1  1/25 (4.00%)  0/1 (0.00%) 
PARANASAL SINUS HYPERSECRETION * 1  1/25 (4.00%)  0/1 (0.00%) 
PLEURAL EFFUSION * 1  1/25 (4.00%)  0/1 (0.00%) 
PULMONARY EMBOLISM * 1  1/25 (4.00%)  0/1 (0.00%) 
SINUS CONGESTION * 1  1/25 (4.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders     
BLISTER * 1  6/25 (24.00%)  0/1 (0.00%) 
DERMATITIS * 1  1/25 (4.00%)  0/1 (0.00%) 
DERMATITIS ACNEIFORM * 1  1/25 (4.00%)  0/1 (0.00%) 
ERYTHEMA * 1  1/25 (4.00%)  0/1 (0.00%) 
HYPERKERATOSIS * 1  2/25 (8.00%)  0/1 (0.00%) 
NIGHT SWEATS * 1  1/25 (4.00%)  0/1 (0.00%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME * 1  4/25 (16.00%)  0/1 (0.00%) 
PRURITUS * 1  1/25 (4.00%)  0/1 (0.00%) 
RASH * 1  3/25 (12.00%)  0/1 (0.00%) 
RASH GENERALISED * 1  1/25 (4.00%)  0/1 (0.00%) 
RASH MACULAR * 1  1/25 (4.00%)  0/1 (0.00%) 
RASH MACULO-PAPULAR * 1  2/25 (8.00%)  0/1 (0.00%) 
RASH PAPULAR * 1  2/25 (8.00%)  0/1 (0.00%) 
SKIN HYPERPIGMENTATION * 1  1/25 (4.00%)  0/1 (0.00%) 
SKIN DISORDER NOT OTHERWISE SPECIFIED * 1  1/25 (4.00%)  0/1 (0.00%) 
Surgical and medical procedures     
CHEST TUBE INSERTION * 1  1/25 (4.00%)  0/1 (0.00%) 
HERNIA REPAIR * 1  1/25 (4.00%)  0/1 (0.00%) 
Vascular disorders     
HOT FLUSH * 1  1/25 (4.00%)  0/1 (0.00%) 
HYPERTENSION * 1  5/25 (20.00%)  0/1 (0.00%) 
HYPERTENSIVE CRISIS * 1  1/25 (4.00%)  0/1 (0.00%) 
PERIPHERAL COLDNESS * 1  1/25 (4.00%)  0/1 (0.00%) 
1
Term from vocabulary, CTCAE (Unspecified)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Regulatory Science
Organization: Sarah Cannon Development Innovations
Phone: 844-710-6157
EMail: CANN.InnovationsMedical@sarahcannon.com
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT02195011     History of Changes
Other Study ID Numbers: SCRI GI 189
First Submitted: July 17, 2014
First Posted: July 21, 2014
Results First Submitted: June 4, 2018
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018