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Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma

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: NCT02243605
Recruitment Status : Active, not recruiting
First Posted : September 18, 2014
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Ewing Sarcoma
Metastatic Osteosarcoma
Recurrent Ewing Sarcoma
Recurrent Osteosarcoma
Stage III Osteosarcoma AJCC v7
Stage IV Osteosarcoma AJCC v7
Stage IVA Osteosarcoma AJCC v7
Stage IVB Osteosarcoma AJCC v7
Unresectable Ewing Sarcoma
Unresectable Osteosarcoma
Interventions Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ewing Sarcoma Osteosarcoma
Hide Arm/Group Description

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :

  • a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).
  • a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising.

Period Title: Stage 1 - Interim Analysis Population
Started 23 22
Completed [1] 21 21
Not Completed 2 1
Reason Not Completed
Protocol Violation             1             1
Adverse Event             1             0
[1]
Eligible and who received at least one complete cycle or two incomplete cycles of treatment.
Period Title: Stage 2 - Final Analysis Population
Started 45 45
Completed [1] 39 42
Not Completed 6 3
Reason Not Completed
Protocol Violation             5             1
Adverse Event             1             1
Progression             0             1
[1]
Eligible and who received at least one complete cycle or two incomplete cycles of treatment.
Arm/Group Title Ewing Sarcoma Osteosarcoma Total
Hide Arm/Group Description

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :

  • a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).
  • a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising.

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
<=18 years
6
  13.3%
7
  15.6%
13
  14.4%
Between 18 and 65 years
38
  84.4%
31
  68.9%
69
  76.7%
>=65 years
1
   2.2%
7
  15.6%
8
   8.9%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
33
(24 to 45)
34
(20 to 53)
34
(21 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
14
  31.1%
18
  40.0%
32
  35.6%
Male
31
  68.9%
27
  60.0%
58
  64.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title Non-progression at 6 Months - Osteosarcoma
Hide Description

Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients eligible and who received at least one complete or two incomplete treatment cycles.
Arm/Group Title Osteosarcoma
Hide Arm/Group Description:

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :

  • a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).
  • a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising.

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
33.3
(19.6 to 49.6)
2.Primary Outcome
Title Objective Response Within 6 Months of Treatment Onset - Osteosarcoma
Hide Description

Objective response defined as complete response (CR) or partial response (PR) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, CR is defined as disappearance of all target and non-target lesions and normalization of tumour marker level of non-target lesions. All lymph nodes must be non-pathological in size (<10 mm short axis).

As per revised RECIST v1.1, PR is defined as a at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and non-PD/not all evaluated non-target lesions, or, CR of target lesions and non-CR/non-PD/not evaluated non-target lesions.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Time Frame Within 6 months of treatment onset
Hide Outcome Measure Data
Hide Analysis Population Description
All patients eligible and who received at least one complete or two incomplete treatment cycles.
Arm/Group Title Osteosarcoma
Hide Arm/Group Description:

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II trial based on 2-stage dual endpoint design with 41 evaluable patients (first stage: 21 patients) used to distinguish :

  • a favorable true 6-month non-progression rate of 50% from a null rate of 25% (92% power).
  • a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset or <=6 6-month non-progression, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset or >=16 6-month non-progression, Cabozantinib was considered promising.

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
11.9
(4.0 to 25.6)
3.Primary Outcome
Title Objective Response Within 6 Months of Treatment Onset - Ewing Sarcoma
Hide Description

Objective response defined as complete response (CR) or partial response (PR) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, CR is defined as disappearance of all target and non-target lesions and normalization of tumour marker level of non-target lesions. All lymph nodes must be non-pathological in size (<10 mm short axis).

As per revised RECIST v1.1, PR is defined as a at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and non-PD/not all evaluated non-target lesions, or, CR of target lesions and non-CR/non-PD/not evaluated non-target lesions.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Time Frame Within 6 months of treatment onset
Hide Outcome Measure Data
Hide Analysis Population Description
All patients eligible and who received at least one complete or two incomplete treatment cycles.
Arm/Group Title Ewing Sarcoma
Hide Arm/Group Description:

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.

Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
25.6
(13.0 to 42.1)
4.Secondary Outcome
Title Best Overall Response
Hide Description Will be analyzed independently for each stratum (osteosarcoma and Ewing sarcoma). Will be described using frequency, percentage, and 95% confidence interval (binomial law).
Time Frame From the start of the treatment until disease progression/recurrence, assessed up to 2 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Will be analyzed independently for each stratum (osteosarcoma and Ewing sarcoma). PFS will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method. Multivariate analyses can also be carried out based on Cox's proportional risk method and after checking the risk proportionality hypothesis.
Time Frame Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Will be analyzed independently for each stratum (osteosarcoma and Ewing sarcoma). OS will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method. Multivariate analyses can also be carried out based on Cox's proportional risk method and after checking the risk proportionality hypothesis.
Time Frame Time from start of treatment to the time of death, assessed up to 2 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Incidence of Adverse Events
Hide Description Will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4. Quantitative variables will be described using mean and standard errors if the normality assumption is satisfied, else other descriptive statistics (median, range, quartiles) will be used. Qualitative variables will be described using frequency, percentage, and 95% confidence interval.
Time Frame Up to 2 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Non-progression at 6 Months - Ewing Sarcoma
Hide Description

Non-progression defined as complete response (CR), partial response (PR), or stable disease (SD) as per the Response Evaluation Criteria In Solid Tumors Criteria, revised RECIST v1.1.

As per revised RECIST v1.1, progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients eligible and who received at least one complete or two incomplete treatment cycles.
Arm/Group Title Ewing Sarcoma
Hide Arm/Group Description:

Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 41 evaluable patients (first stage: 21 patients) used to distinguish a favorable true objective response rate within 6 months of treatment onset of 20% from a null rate of 5% (90% power and 5% type I error).

Stage 1(21 evaluable patients): if <=1 objective response within 6 months of treatment onset, the study was stopped early. Otherwise, the second group of 20 participants was recruited.

Stage 2 (41 evaluable patients): if >= 5 objective response within 6 months of treatment onset, Cabozantinib was considered promising.

Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
25.6
(13.0 to 42.1)
Time Frame Osteosarcoma : 26 months of treatment. At the time of primary analysis, 3 were still on treatment and 42 patients discontinued treatment. Ewing sarcoma : 20 months of treatment. At the time of primary analysis, 3 were still on treatment and 42 patients discontinued treatment.
Adverse Event Reporting Description

Adverse event are reported for all treated patients who received at least one administration of treatment.

All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.

 
Arm/Group Title Osteosarcoma Ewing Sarcoma
Hide Arm/Group Description Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cabozantinib s-malate PO QD on days 1-28. 60 mg for patients ≥ 16 years and 40mg/m² for patients ≥ 12 years and <16 years. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Osteosarcoma Ewing Sarcoma
Affected / at Risk (%) Affected / at Risk (%)
Total   34/45 (75.56%)      30/45 (66.67%)    
Hide Serious Adverse Events
Osteosarcoma Ewing Sarcoma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/45 (66.67%)      31/45 (68.89%)    
Blood and lymphatic system disorders     
Anemia  1  1/45 (2.22%)  1 2/45 (4.44%)  2
Febrile neutropenia  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Cardiac disorders     
Pericardial effusion  1  2/45 (4.44%)  2 1/45 (2.22%)  1
Cardiac disorders - Other, specify  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Rectal hemorrhage  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  1/45 (2.22%)  1 0/45 (0.00%)  0
General disorders     
Death NOS  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Fatigue  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Fever  1  1/45 (2.22%)  1 1/45 (2.22%)  1
General disorders and administration site conditions - Other, specify  1  2/45 (4.44%)  2 3/45 (6.67%)  3
Disease progression  1  2/45 (4.44%)  2 4/45 (8.89%)  4
Hepatobiliary disorders     
Hepatobiliary disorders - Other, specify  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations     
Anorectal infection  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Bronchial infection  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Kidney infection  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Sepsis  1  2/45 (4.44%)  2 0/45 (0.00%)  0
Soft tissue infection  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Infections and infestations - Other, specify  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Injury, poisoning and procedural complications     
Wound complication  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Investigations     
GGT increased  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Lipase increased  1  1/45 (2.22%)  1 1/45 (2.22%)  1
Lymphocyte count decreased  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Neutrophil count decreased  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Platelet count decreased  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Investigations - Other, specify  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Metabolism and nutrition disorders     
Hypomagnesemia  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Metabolism and nutrition disorders - Other, specify  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/45 (0.00%)  0 5/45 (11.11%)  5
Chest wall pain  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  3/45 (6.67%)  3 2/45 (4.44%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/45 (2.22%)  1 1/45 (2.22%)  1
Nervous system disorders     
Peripheral motor neuropathy  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Nervous system disorders - Other, specify  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Spinal cord compression  1  1/45 (2.22%)  1 3/45 (6.67%)  3
Psychiatric disorders     
Psychiatric disorders - Other, specify  1  0/45 (0.00%)  0 1/45 (2.22%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  2/45 (4.44%)  2 2/45 (4.44%)  2
Epistaxis  1  1/45 (2.22%)  1 0/45 (0.00%)  0
Pleural effusion  1  7/45 (15.56%)  7 2/45 (4.44%)  2
Pneumothorax  1  11/45 (24.44%)  11 14/45 (31.11%)  14
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/45 (2.22%)  1 3/45 (6.67%)  3
Skin and subcutaneous tissue disorders     
Skin ulceration  1  2/45 (4.44%)  2 0/45 (0.00%)  0
Vascular disorders     
Thromboembolic event  1  2/45 (4.44%)  2 0/45 (0.00%)  0
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Osteosarcoma Ewing Sarcoma
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/45 (100.00%)      45/45 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  6/45 (13.33%)  7 8/45 (17.78%)  10
Cardiac disorders     
Sinus tachycardia  1  3/45 (6.67%)  3 4/45 (8.89%)  4
Endocrine disorders     
Hypothyroidism  1  23/45 (51.11%)  25 21/45 (46.67%)  23
Eye disorders     
Blurred vision  1  1/45 (2.22%)  1 4/45 (8.89%)  4
Gastrointestinal disorders     
Abdominal pain  1  8/45 (17.78%)  10 12/45 (26.67%)  12
Constipation  1  14/45 (31.11%)  20 14/45 (31.11%)  19
Diarrhea  1  30/45 (66.67%)  45 33/45 (73.33%)  46
Dry mouth  1  1/45 (2.22%)  1 7/45 (15.56%)  7
Dysphagia  1  2/45 (4.44%)  2 3/45 (6.67%)  3
Gastroesophageal reflux disease  1  4/45 (8.89%)  4 7/45 (15.56%)  8
Gastrointestinal pain  1  2/45 (4.44%)  2 3/45 (6.67%)  3
Hemorrhoids  1  2/45 (4.44%)  2 3/45 (6.67%)  3
Mucositis oral  1  25/45 (55.56%)  30 24/45 (53.33%)  29
Nausea  1  19/45 (42.22%)  22 15/45 (33.33%)  18
Toothache  1  3/45 (6.67%)  3 2/45 (4.44%)  2
Vomiting  1  7/45 (15.56%)  9 10/45 (22.22%)  12
Gastrointestinal disorders - Other, specify  1  12/45 (26.67%)  13 9/45 (20.00%)  11
General disorders     
Fatigue  1  34/45 (75.56%)  41 32/45 (71.11%)  36
Fever  1  8/45 (17.78%)  11 7/45 (15.56%)  8
Non-cardiac chest pain  1  8/45 (17.78%)  11 3/45 (6.67%)  3
Pain  1  8/45 (17.78%)  9 7/45 (15.56%)  8
General disorders and administration site conditions - Other, specify  1  6/45 (13.33%)  6 4/45 (8.89%)  4
Disease progression  1  2/45 (4.44%)  2 4/45 (8.89%)  4
Infections and infestations     
Bronchial infection  1  4/45 (8.89%)  7 3/45 (6.67%)  3
Pharyngitis  1  1/45 (2.22%)  1 4/45 (8.89%)  4
Rhinitis infective  1  4/45 (8.89%)  4 1/45 (2.22%)  1
Skin infection  1  1/45 (2.22%)  1 3/45 (6.67%)  3
Infections and infestations - Other, specify  1  8/45 (17.78%)  8 6/45 (13.33%)  7
Injury, poisoning and procedural complications     
Fall  1  3/45 (6.67%)  3 0/45 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  21/45 (46.67%)  25 22/45 (48.89%)  27
Alkaline phosphatase increased  1  6/45 (13.33%)  6 7/45 (15.56%)  9
Aspartate aminotransferase increased  1  23/45 (51.11%)  28 22/45 (48.89%)  27
Blood bilirubin increased  1  3/45 (6.67%)  3 3/45 (6.67%)  3
CPK increased  1  1/45 (2.22%)  1 4/45 (8.89%)  6
Electrocardiogram QT corrected interval prolonged  1  4/45 (8.89%)  4 0/45 (0.00%)  0
GGT increased  1  2/45 (4.44%)  2 5/45 (11.11%)  5
Lipase increased  1  9/45 (20.00%)  16 4/45 (8.89%)  5
Lymphocyte count decreased  1  3/45 (6.67%)  5 3/45 (6.67%)  5
Neutrophil count decreased  1  9/45 (20.00%)  11 10/45 (22.22%)  11
Platelet count decreased  1  13/45 (28.89%)  13 19/45 (42.22%)  21
Serum amylase increased  1  4/45 (8.89%)  4 2/45 (4.44%)  2
Weight loss  1  14/45 (31.11%)  14 14/45 (31.11%)  14
White blood cell decreased  1  3/45 (6.67%)  5 5/45 (11.11%)  7
Investigations - Other, specify  1  2/45 (4.44%)  4 5/45 (11.11%)  5
Blood lactate dehydrogenase increased  1  5/45 (11.11%)  7 5/45 (11.11%)  6
Thyroid stimulating hormone increased  1  6/45 (13.33%)  6 4/45 (8.89%)  4
Metabolism and nutrition disorders     
Anorexia  1  23/45 (51.11%)  27 11/45 (24.44%)  13
Hypoalbuminemia  1  3/45 (6.67%)  3 3/45 (6.67%)  3
Hypocalcemia  1  6/45 (13.33%)  9 3/45 (6.67%)  4
Hypokalemia  1  8/45 (17.78%)  14 4/45 (8.89%)  4
Hypomagnesemia  1  12/45 (26.67%)  18 6/45 (13.33%)  7
Hypophosphatemia  1  11/45 (24.44%)  12 15/45 (33.33%)  21
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/45 (6.67%)  3 4/45 (8.89%)  4
Back pain  1  8/45 (17.78%)  8 12/45 (26.67%)  15
Bone pain  1  1/45 (2.22%)  1 9/45 (20.00%)  9
Myalgia  1  6/45 (13.33%)  7 6/45 (13.33%)  8
Pain in extremity  1  3/45 (6.67%)  3 1/45 (2.22%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  9/45 (20.00%)  9 5/45 (11.11%)  6
Muscle cramp  1  0/45 (0.00%)  0 3/45 (6.67%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  8/45 (17.78%)  10 4/45 (8.89%)  5
Nervous system disorders     
Dysgeusia  1  9/45 (20.00%)  10 14/45 (31.11%)  14
Headache  1  7/45 (15.56%)  10 10/45 (22.22%)  12
Nervous system disorders - Other, specify  1  4/45 (8.89%)  5 0/45 (0.00%)  0
Spinal cord compression  1  0/45 (0.00%)  0 4/45 (8.89%)  4
Psychiatric disorders     
Anxiety  1  5/45 (11.11%)  5 2/45 (4.44%)  2
Depression  1  5/45 (11.11%)  5 2/45 (4.44%)  2
Insomnia  1  6/45 (13.33%)  6 2/45 (4.44%)  2
Renal and urinary disorders     
Proteinuria  1  6/45 (13.33%)  8 4/45 (8.89%)  5
Renal and urinary disorders - Other, specify  1  3/45 (6.67%)  3 0/45 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  11/45 (24.44%)  14 10/45 (22.22%)  12
Dyspnea  1  12/45 (26.67%)  12 7/45 (15.56%)  8
Epistaxis  1  8/45 (17.78%)  8 4/45 (8.89%)  5
Pleural effusion  1  9/45 (20.00%)  10 3/45 (6.67%)  3
Pneumothorax  1  10/45 (22.22%)  11 10/45 (22.22%)  15
Voice alteration  1  10/45 (22.22%)  11 4/45 (8.89%)  4
Respiratory, thoracic and mediastinal disorders - Other, specify  1  7/45 (15.56%)  7 5/45 (11.11%)  6
Skin and subcutaneous tissue disorders     
Alopecia  1  6/45 (13.33%)  6 6/45 (13.33%)  6
Dry skin  1  13/45 (28.89%)  14 16/45 (35.56%)  18
Erythema multiforme  1  4/45 (8.89%)  5 5/45 (11.11%)  5
Palmar-plantar erythrodysesthesia syndrome  1  14/45 (31.11%)  14 18/45 (40.00%)  21
Rash acneiform  1  3/45 (6.67%)  3 1/45 (2.22%)  1
Rash maculo-papular  1  4/45 (8.89%)  4 1/45 (2.22%)  1
Skin hypopigmentation  1  5/45 (11.11%)  5 5/45 (11.11%)  5
Skin ulceration  1  6/45 (13.33%)  8 2/45 (4.44%)  2
Skin and subcutaneous tissue disorders - Other, specify  1  22/45 (48.89%)  34 9/45 (20.00%)  14
Hair color changes  1  15/45 (33.33%)  15 15/45 (33.33%)  15
Vascular disorders     
Hypertension  1  7/45 (15.56%)  9 3/45 (6.67%)  3
Thromboembolic event  1  5/45 (11.11%)  5 0/45 (0.00%)  0
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by 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: Pr Italiano Antoine, Department of Medical Oncology
Organization: Institut Bergonie
Phone: 0524071947
EMail: a.italiano@bordeaux.unicancer.fr
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02243605    
Other Study ID Numbers: NCI-2014-01927
NCI-2014-01927 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CABONE
9620 ( Other Identifier: Institut Bergonie Cancer Center )
9620 ( Other Identifier: CTEP )
First Submitted: September 16, 2014
First Posted: September 18, 2014
Results First Submitted: July 20, 2020
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020