Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer

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: NCT02393755
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Boehringer Ingelheim
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colon Adenocarcinoma
Rectal Adenocarcinoma
Recurrent Colon Carcinoma
Recurrent Rectal Carcinoma
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions Drug: Capecitabine
Other: Laboratory Biomarker Analysis
Drug: Nintedanib
Other: Pharmacological Study
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1: Capecitabine at 2000 mg/2, Nintedanib at 150 mg Dose Level 2: Capecitabine at 2000 mg/m2, Nintedanib at 200 mg
Hide Arm/Group Description

Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid

Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.

Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid

Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.

Period Title: Overall Study
Started 3 39
Completed 3 32
Not Completed 0 7
Reason Not Completed
Withdrawal by Subject             0             3
Adverse Event             0             2
Physician Decision             0             2
Arm/Group Title Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg Total
Hide Arm/Group Description

Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid

Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.

Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid

Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.

Total of all reporting groups
Overall Number of Baseline Participants 3 39 42
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 39 participants 42 participants
61.0
(55 to 63)
57.3
(35 to 77)
57.6
(35 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 39 participants 42 participants
Female
2
  66.7%
22
  56.4%
24
  57.1%
Male
1
  33.3%
17
  43.6%
18
  42.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 39 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
5
  12.8%
5
  11.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.6%
1
   2.4%
White
3
 100.0%
30
  76.9%
33
  78.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
   7.7%
3
   7.1%
ECOG Status at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 39 participants 42 participants
Grade 0
2
  66.7%
21
  53.8%
23
  54.8%
Grade 1
1
  33.3%
18
  46.2%
19
  45.2%
[1]
Measure Description:

ECOG Performance Status, Developed by the Eastern Cooperative Oncology Group, Robert L. Comis, MD

GRADE

0. Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
Body Weight  
Mean (Full Range)
Unit of measure:  Kilograms (kg)
Number Analyzed 3 participants 39 participants 42 participants
69.2
(57.6 to 90.4)
77.8
(41.1 to 126)
77.2
(41.1 to 126)
Presence of liver metastasis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 39 participants 42 participants
3
 100.0%
20
  51.3%
23
  54.8%
1.Primary Outcome
Title To Examine the DLT
Hide Description

The recommended Phase II dose is of the Nintedanib and Capecitabine combination is defined as the dose level that causes dose limiting toxicities (DLTs) in ≤ 1 out of 6 patients at highest dose level below the maximally administered dose.

Capecitabine is fixed dose at 2000 mg/m2; while Nintedanib is evaluated at 150mg (dose level 1) and 200 mg (dose level 2).

Time Frame At least 21 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were evaluable for DLTs
Arm/Group Title Treatment (Capecitabine, Nintedanib)
Hide Arm/Group Description:

Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: mg
200
2.Primary Outcome
Title Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II)
Hide Description

Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions.

Will be summarized using standard Kaplan-Meier methods.

Time Frame At 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients at dose level 2
Arm/Group Title Treatment (Capecitabine, Nintedanib)
Hide Arm/Group Description:

Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
41.7
(29.2 to 55.3)
3.Secondary Outcome
Title Median PFS (Phase II)
Hide Description Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions. Estimates of median PFS will be obtained with corresponding 90% confidence intervals.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients at dose level 2
Arm/Group Title Treatment (Capecitabine, Nintedanib)
Hide Arm/Group Description:

Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 36
Median (90% Confidence Interval)
Unit of Measure: months
3.4
(2.1 to 4.2)
4.Secondary Outcome
Title Median OS (Phase II)
Hide Description Overall survival is defined as time from date of subject enrollment to the date of death due to any cause. Estimates of median OS will be obtained with corresponding 90% confidence intervals.
Time Frame From the date of enrollment to the time of death, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients at dose level 2
Arm/Group Title Treatment (Capecitabine, Nintedanib)
Hide Arm/Group Description:

Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 36
Median (90% Confidence Interval)
Unit of Measure: months
8.9
(5.9 to 13.8)
5.Secondary Outcome
Title Objective Response Rate
Hide Description Overall Response is defined as Complete Response: Disappearance of all target lesions and any lymph nodes must have a reduction in short axis to < 10 mm; or Partial Response: At least a 30% decrease in the sum of diameters of target lesions; or Stable Disease: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease.
Time Frame After every 3 cycles (9 weeks) of therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients at dose level 2
Arm/Group Title Treatment (Capecitabine, Nintedanib)
Hide Arm/Group Description:

Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
58.3
(44.7 to 70.8)
6.Secondary Outcome
Title Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Hide Description Number of Participants with Adverse Events, Graded According to the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).
Time Frame Up to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients at dose level 2
Arm/Group Title Treatment (Capecitabine, Nintedanib)
Hide Arm/Group Description:

Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nintedanib: Given PO

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
3
   8.3%
Grade 2
13
  36.1%
Grade 3
16
  44.4%
Grade 4
1
   2.8%
Grade 5
3
   8.3%
Time Frame Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
Adverse Event Reporting Description All treated and eligible patients
 
Arm/Group Title Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
Hide Arm/Group Description

Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid

Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.

Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid

Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.

All-Cause Mortality
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)      32/39 (82.05%)    
Hide Serious Adverse Events
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      10/39 (25.64%)    
Gastrointestinal disorders     
Abdominal pain   0/3 (0.00%)  0 1/39 (2.56%)  1
Constipation   0/3 (0.00%)  0 1/39 (2.56%)  1
Intestinal perforation   0/3 (0.00%)  0 1/39 (2.56%)  1
Small intestinal obstruction   0/3 (0.00%)  0 1/39 (2.56%)  1
Hepatobiliary disorders     
Hepatic failure   0/3 (0.00%)  0 1/39 (2.56%)  1
Infections and infestations     
Gastroenteritis   0/3 (0.00%)  0 1/39 (2.56%)  1
Sepsis   0/3 (0.00%)  0 1/39 (2.56%)  1
Investigations     
Alanine aminotransferase increased   0/3 (0.00%)  0 1/39 (2.56%)  1
Metabolism and nutrition disorders     
Dehydration   0/3 (0.00%)  0 1/39 (2.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system   0/3 (0.00%)  0 1/39 (2.56%)  1
Neoplasm malignant   0/3 (0.00%)  0 1/39 (2.56%)  1
Psychiatric disorders     
Mental status changes   0/3 (0.00%)  0 1/39 (2.56%)  1
Renal and urinary disorders     
Urinary retention   0/3 (0.00%)  0 1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural effusion   0/3 (0.00%)  0 1/39 (2.56%)  2
Respiratory failure   0/3 (0.00%)  0 1/39 (2.56%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      39/39 (100.00%)    
Blood and lymphatic system disorders     
Anaemia   1/3 (33.33%)  1 14/39 (35.90%)  25
Lymphadenopathy   0/3 (0.00%)  0 1/39 (2.56%)  1
Lymphopenia   0/3 (0.00%)  0 5/39 (12.82%)  8
Thrombocytopenia   0/3 (0.00%)  0 1/39 (2.56%)  1
Cardiac disorders     
Cardiac disorder   0/3 (0.00%)  0 2/39 (5.13%)  2
Pericardial effusion   0/3 (0.00%)  0 1/39 (2.56%)  1
Tachycardia   0/3 (0.00%)  0 1/39 (2.56%)  1
Eye disorders     
Dry eye   0/3 (0.00%)  0 1/39 (2.56%)  1
Eye irritation   0/3 (0.00%)  0 1/39 (2.56%)  1
Lacrimation increased   0/3 (0.00%)  0 2/39 (5.13%)  2
Ocular hyperaemia   0/3 (0.00%)  0 1/39 (2.56%)  1
Vision blurred   0/3 (0.00%)  0 3/39 (7.69%)  3
Gastrointestinal disorders     
Abdominal discomfort   0/3 (0.00%)  0 1/39 (2.56%)  1
Abdominal distension   0/3 (0.00%)  0 5/39 (12.82%)  6
Abdominal pain   1/3 (33.33%)  1 10/39 (25.64%)  10
Abdominal pain upper   0/3 (0.00%)  0 3/39 (7.69%)  3
Ascites   1/3 (33.33%)  1 2/39 (5.13%)  2
Cheilitis   0/3 (0.00%)  0 1/39 (2.56%)  1
Colitis   0/3 (0.00%)  0 1/39 (2.56%)  1
Constipation   1/3 (33.33%)  1 11/39 (28.21%)  14
Diarrhoea   2/3 (66.67%)  4 22/39 (56.41%)  49
Dry mouth   0/3 (0.00%)  0 3/39 (7.69%)  3
Flatulence   1/3 (33.33%)  1 3/39 (7.69%)  3
Gastrooesophageal reflux disease   0/3 (0.00%)  0 1/39 (2.56%)  1
Gingival bleeding   0/3 (0.00%)  0 1/39 (2.56%)  1
Haematochezia   0/3 (0.00%)  0 2/39 (5.13%)  2
Haemorrhoids   0/3 (0.00%)  0 1/39 (2.56%)  1
Large intestinal obstruction   0/3 (0.00%)  0 1/39 (2.56%)  1
Nausea   3/3 (100.00%)  6 27/39 (69.23%)  45
Oral pain   0/3 (0.00%)  0 2/39 (5.13%)  2
Rectal haemorrhage   0/3 (0.00%)  0 1/39 (2.56%)  1
Salivary hypersecretion   0/3 (0.00%)  0 1/39 (2.56%)  1
Small intestinal obstruction   0/3 (0.00%)  0 1/39 (2.56%)  1
Stomatitis   2/3 (66.67%)  7 5/39 (12.82%)  5
Vomiting   3/3 (100.00%)  3 26/39 (66.67%)  45
General disorders     
Asthenia   0/3 (0.00%)  0 2/39 (5.13%)  2
Chills   0/3 (0.00%)  0 3/39 (7.69%)  3
Fatigue   3/3 (100.00%)  4 23/39 (58.97%)  48
Influenza like illness   0/3 (0.00%)  0 1/39 (2.56%)  1
Medical device pain   0/3 (0.00%)  0 1/39 (2.56%)  1
Mucosal inflammation   0/3 (0.00%)  0 2/39 (5.13%)  4
Non-cardiac chest pain   1/3 (33.33%)  1 1/39 (2.56%)  2
Oedema   0/3 (0.00%)  0 1/39 (2.56%)  1
Oedema peripheral   0/3 (0.00%)  0 2/39 (5.13%)  2
Pain   0/3 (0.00%)  0 1/39 (2.56%)  1
Pyrexia   1/3 (33.33%)  2 6/39 (15.38%)  6
Swelling   0/3 (0.00%)  0 1/39 (2.56%)  1
Hepatobiliary disorders     
Biliary colic   0/3 (0.00%)  0 1/39 (2.56%)  1
Hyperbilirubinaemia   1/3 (33.33%)  1 3/39 (7.69%)  6
Infections and infestations     
Bronchitis   0/3 (0.00%)  0 1/39 (2.56%)  1
Influenza   0/3 (0.00%)  0 1/39 (2.56%)  1
Legionella infection   0/3 (0.00%)  0 1/39 (2.56%)  1
Nasopharyngitis   1/3 (33.33%)  1 1/39 (2.56%)  1
Pneumonia   0/3 (0.00%)  0 2/39 (5.13%)  3
Urinary tract infection   1/3 (33.33%)  2 1/39 (2.56%)  1
Urinary tract infection enterococcal   0/3 (0.00%)  0 1/39 (2.56%)  1
Viral infection   0/3 (0.00%)  0 1/39 (2.56%)  1
Injury, poisoning and procedural complications     
Contusion   0/3 (0.00%)  0 1/39 (2.56%)  1
Fall   1/3 (33.33%)  1 1/39 (2.56%)  1
Spinal fracture   1/3 (33.33%)  1 0/39 (0.00%)  0
Traumatic haematoma   0/3 (0.00%)  0 1/39 (2.56%)  1
Investigations     
Alanine aminotransferase   0/3 (0.00%)  0 1/39 (2.56%)  1
Alanine aminotransferase increased   0/3 (0.00%)  0 16/39 (41.03%)  23
Aspartate aminotransferase   0/3 (0.00%)  0 2/39 (5.13%)  2
Aspartate aminotransferase increased   3/3 (100.00%)  4 19/39 (48.72%)  31
Blood albumin decreased   0/3 (0.00%)  0 1/39 (2.56%)  1
Blood alkaline phosphatase   0/3 (0.00%)  0 1/39 (2.56%)  1
Blood alkaline phosphatase increased   0/3 (0.00%)  0 16/39 (41.03%)  25
Blood bilirubin increased   0/3 (0.00%)  0 10/39 (25.64%)  16
Blood creatinine increased   0/3 (0.00%)  0 1/39 (2.56%)  5
Blood sodium decreased   0/3 (0.00%)  0 1/39 (2.56%)  1
Neutrophil count decreased   0/3 (0.00%)  0 1/39 (2.56%)  1
Platelet count   0/3 (0.00%)  0 1/39 (2.56%)  1
Platelet count decreased   0/3 (0.00%)  0 2/39 (5.13%)  3
Serum ferritin decreased   0/3 (0.00%)  0 1/39 (2.56%)  1
Transferrin saturation decreased   0/3 (0.00%)  0 1/39 (2.56%)  1
Urine protein, quantitative   0/3 (0.00%)  0 1/39 (2.56%)  1
Weight decreased   1/3 (33.33%)  1 7/39 (17.95%)  10
White blood cell count decreased   0/3 (0.00%)  0 5/39 (12.82%)  7
Metabolism and nutrition disorders     
Decreased appetite   1/3 (33.33%)  2 16/39 (41.03%)  27
Dehydration   0/3 (0.00%)  0 4/39 (10.26%)  4
Electrolyte imbalance   0/3 (0.00%)  0 1/39 (2.56%)  1
Hypercalcaemia   0/3 (0.00%)  0 1/39 (2.56%)  1
Hyperglycaemia   1/3 (33.33%)  1 2/39 (5.13%)  2
Hyperkalaemia   0/3 (0.00%)  0 1/39 (2.56%)  1
Hypernatraemia   0/3 (0.00%)  0 2/39 (5.13%)  2
Hyperuricaemia   0/3 (0.00%)  0 1/39 (2.56%)  1
Hypoalbuminaemia   0/3 (0.00%)  0 11/39 (28.21%)  25
Hypocalcaemia   0/3 (0.00%)  0 2/39 (5.13%)  2
Hypokalaemia   0/3 (0.00%)  0 5/39 (12.82%)  9
Hyponatraemia   1/3 (33.33%)  1 10/39 (25.64%)  13
Hypophosphataemia   0/3 (0.00%)  0 1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia   0/3 (0.00%)  0 4/39 (10.26%)  4
Back pain   0/3 (0.00%)  0 5/39 (12.82%)  7
Bone pain   0/3 (0.00%)  0 1/39 (2.56%)  1
Flank pain   0/3 (0.00%)  0 1/39 (2.56%)  1
Muscular weakness   1/3 (33.33%)  2 3/39 (7.69%)  4
Musculoskeletal discomfort   0/3 (0.00%)  0 1/39 (2.56%)  1
Musculoskeletal pain   0/3 (0.00%)  0 1/39 (2.56%)  2
Myalgia   0/3 (0.00%)  0 2/39 (5.13%)  2
Neck pain   0/3 (0.00%)  0 1/39 (2.56%)  1
Pain in extremity   0/3 (0.00%)  0 3/39 (7.69%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bone marrow leukaemic cell infiltration   0/3 (0.00%)  0 1/39 (2.56%)  1
Nervous system disorders     
Dizziness   0/3 (0.00%)  0 8/39 (20.51%)  8
Dysarthria   1/3 (33.33%)  1 1/39 (2.56%)  1
Dysgeusia   1/3 (33.33%)  1 0/39 (0.00%)  0
Headache   0/3 (0.00%)  0 8/39 (20.51%)  9
Lethargy   0/3 (0.00%)  0 1/39 (2.56%)  1
Neuropathy peripheral   1/3 (33.33%)  1 9/39 (23.08%)  10
Paraesthesia   0/3 (0.00%)  0 1/39 (2.56%)  1
Taste disorder   0/3 (0.00%)  0 4/39 (10.26%)  4
Psychiatric disorders     
Anxiety   0/3 (0.00%)  0 2/39 (5.13%)  2
Catatonia   0/3 (0.00%)  0 1/39 (2.56%)  1
Confusional state   0/3 (0.00%)  0 1/39 (2.56%)  1
Mental disorder   0/3 (0.00%)  0 1/39 (2.56%)  1
Renal and urinary disorders     
Acute kidney injury   0/3 (0.00%)  0 1/39 (2.56%)  1
Haematuria   0/3 (0.00%)  0 2/39 (5.13%)  7
Nephrolithiasis   0/3 (0.00%)  0 1/39 (2.56%)  1
Proteinuria   0/3 (0.00%)  0 2/39 (5.13%)  3
Renal injury   0/3 (0.00%)  0 1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   0/3 (0.00%)  0 1/39 (2.56%)  1
Cough   0/3 (0.00%)  0 8/39 (20.51%)  12
Dyspnoea   2/3 (66.67%)  3 8/39 (20.51%)  11
Epistaxis   0/3 (0.00%)  0 1/39 (2.56%)  1
Haemoptysis   0/3 (0.00%)  0 1/39 (2.56%)  1
Nasal congestion   0/3 (0.00%)  0 1/39 (2.56%)  1
Oropharyngeal pain   0/3 (0.00%)  0 3/39 (7.69%)  3
Pleural effusion   0/3 (0.00%)  0 4/39 (10.26%)  4
Pneumonitis   0/3 (0.00%)  0 1/39 (2.56%)  1
Productive cough   0/3 (0.00%)  0 2/39 (5.13%)  2
Pulmonary embolism   0/3 (0.00%)  0 2/39 (5.13%)  2
Rhinorrhoea   0/3 (0.00%)  0 1/39 (2.56%)  1
Upper-airway cough syndrome   0/3 (0.00%)  0 1/39 (2.56%)  1
Skin and subcutaneous tissue disorders     
Alopecia   0/3 (0.00%)  0 1/39 (2.56%)  1
Blister   0/3 (0.00%)  0 1/39 (2.56%)  1
Dry skin   0/3 (0.00%)  0 8/39 (20.51%)  9
Erythema   0/3 (0.00%)  0 3/39 (7.69%)  3
Nail disorder   0/3 (0.00%)  0 2/39 (5.13%)  2
Night sweats   0/3 (0.00%)  0 1/39 (2.56%)  1
Palmar-plantar erythrodysaesthesia syndrome   2/3 (66.67%)  11 15/39 (38.46%)  36
Pruritus   0/3 (0.00%)  0 2/39 (5.13%)  2
Rash   0/3 (0.00%)  0 1/39 (2.56%)  1
Rash papular   0/3 (0.00%)  0 1/39 (2.56%)  1
Skin disorder   0/3 (0.00%)  0 2/39 (5.13%)  2
Skin exfoliation   0/3 (0.00%)  0 3/39 (7.69%)  3
Skin hyperpigmentation   0/3 (0.00%)  0 1/39 (2.56%)  1
Skin hypertrophy   0/3 (0.00%)  0 1/39 (2.56%)  1
Vascular disorders     
Deep vein thrombosis   0/3 (0.00%)  0 3/39 (7.69%)  3
Hot flush   0/3 (0.00%)  0 2/39 (5.13%)  2
Hypertension   2/3 (66.67%)  7 9/39 (23.08%)  32
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
EMail: Adrienne.Groman@RoswellPark.org
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02393755    
Other Study ID Numbers: I 265514
NCI-2015-00223 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 265514 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: March 13, 2015
First Posted: March 19, 2015
Results First Submitted: July 12, 2019
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020