PreToxE: Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
Sponsor
Institut Bergonié (Other)
Overall Status
Completed
CT.gov ID
NCT02751827
Collaborator
Agence Nationale de sécurité du Médicament (Other)
312
2
45.5
156
3.4
Study Details
Study Description
Brief Summary
In order to assess the important issue of the safety of antiangiogenic TKI in geriatric population we set up this project which aims to identify, among clinical, biological, pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 70 year-old.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a prospective cohort with collection of biological samples, including 300 patients > 70 year-old treated in multicenter with antiangiogenic TKI regularly approved for metastatic cancers. Data on clinical and biological characteristics of the patient, disease and treatment as well as pharmacogenomics will be centrally collected at the beginning of the treatment. Drug exposure-safety analyses will be performed through assessment of drug through levels (Cmin). Primary endpoint is severe toxicity defined as treatment-related death, hospitalization or disruption of treatment for more than three weeks.
Study Design
Study Type:
Observational
Actual Enrollment
:
312 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
Actual Study Start Date
:
Feb 2, 2016
Actual Primary Completion Date
:
Nov 19, 2019
Actual Study Completion Date
:
Nov 19, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prospective cohort Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major. All eligible patients who have received at least one TKI administration were included in analysis. |
Other: Blood sample
One blood sample before treatment initiation (Cycle 1 Day predose) for pharmacogenomics
One blood sample at the end of the firth month of treatment (postdose) for pharmacokinetic
|
| Retrospective cohort A Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major. All eligible patients who have received at least one TKI administration were included in analysis. |
|
| Retrospective cohort B Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major. All eligible patients who have received at least one TKI administration were included in analysis. |
Outcome Measures
Primary Outcome Measures
- Rate of Severe Toxicity [During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.]
Severe toxicity was defined as any TKI-related adverse events (AE) leading to any one of the following events: death, persistent or significant disability/incapacity (defined as a permanent physical or mental impairmentwhich seriously limits one or more functional capacities such as mobility, communication, self-care, self-direction, or interpersonal skills), unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. All adverse events (AE) were graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0).
Eligibility Criteria
Criteria
Ages Eligible for Study:
70 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥ 70 years
-
Treatment with pazopanib, regorafenib, sorafenib, sunitinib,axitinib in the context of market authorization
-
Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria:
-
Patient treated in a context of clinical trial
-
Patient with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Bergonié | Bordeaux | France | 33076 | |
| 2 | Centre Léon Bérard | Lyon Cedex 08 | France | 69373 |
Sponsors and Collaborators
- Institut Bergonié
- Agence Nationale de sécurité du Médicament
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT02751827
Other Study ID Numbers:
- IB 2015-02
First Posted:
Apr 26, 2016
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B |
|---|---|---|---|
| Arm/Group Description | Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). |
| Period Title: Overall Study | |||
| STARTED | 41 | 171 | 100 |
| COMPLETED | 41 | 171 | 99 |
| NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B | Total |
|---|---|---|---|---|
| Arm/Group Description | Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Total of all reporting groups |
| Overall Participants | 41 | 171 | 99 | 311 |
| Age (years) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [years] |
79
|
74
|
76
|
75
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
16
39%
|
98
57.3%
|
36
36.4%
|
150
48.2%
|
| Male |
25
61%
|
73
42.7%
|
63
63.6%
|
161
51.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
| Region of Enrollment (Count of Participants) | ||||
| France |
41
100%
|
171
100%
|
99
100%
|
311
100%
|
Outcome Measures
| Title | Rate of Severe Toxicity |
|---|---|
| Description | Severe toxicity was defined as any TKI-related adverse events (AE) leading to any one of the following events: death, persistent or significant disability/incapacity (defined as a permanent physical or mental impairmentwhich seriously limits one or more functional capacities such as mobility, communication, self-care, self-direction, or interpersonal skills), unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. All adverse events (AE) were graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0). |
| Time Frame | During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible and assessable population : All eligible patients who have received at least one TKI administration were included in analysis. |
| Arm/Group Title | Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B |
|---|---|---|---|
| Arm/Group Description | Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). |
| Measure Participants | 41 | 171 | 99 |
| Count of Participants [Participants] |
14
34.1%
|
75
43.9%
|
43
43.4%
|
Adverse Events
| Time Frame | During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All AE (all imputability) were collected, excepted for retrospectvie cohort B for which only treatment-related AE were collected. Following study protocol, SAE (i.e severe toxicity) were defined as any AE related to the treatment leading to any one of the following events: death, persistent or significant disability/incapacity, unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation. Hence, no SAE were unrelated to the treatment. | |||||
| Arm/Group Title | Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B | |||
| Arm/Group Description | Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA). | |||
All Cause Mortality |
||||||
| Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/41 (51.2%) | 62/171 (36.3%) | 46/99 (46.5%) | |||
Serious Adverse Events |
||||||
| Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/41 (34.1%) | 75/171 (43.9%) | 43/99 (43.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 0/41 (0%) | 0 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Macrophage activation syndrome | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Cardiac disorders | ||||||
| Chest pain - cardiac | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Left ventricular systolic dysfunction | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 2/99 (2%) | 2 |
| Endocrine disorders | ||||||
| Hypothyroidism | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Diabetes | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Eye disorders | ||||||
| Blurred vision | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 2/41 (4.9%) | 2 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Anal ulcer | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Colonic perforation | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Diarrhea | 0/41 (0%) | 0 | 9/171 (5.3%) | 9 | 5/99 (5.1%) | 5 |
| Dry mouth | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Dyspepsia | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Dysphagia | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Esophagitis | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Gastric hemorrhage | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Gastrointestinal pain | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Mucositis oral | 1/41 (2.4%) | 1 | 6/171 (3.5%) | 6 | 6/99 (6.1%) | 6 |
| Nausea | 1/41 (2.4%) | 1 | 2/171 (1.2%) | 2 | 2/99 (2%) | 2 |
| Periodontal disease | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Rectal hemorrhage | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Vomiting | 1/41 (2.4%) | 1 | 2/171 (1.2%) | 2 | 3/99 (3%) | 3 |
| Digestive problems | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| General disorders | ||||||
| Edema limbs | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Fatigue | 2/41 (4.9%) | 2 | 26/171 (15.2%) | 26 | 17/99 (17.2%) | 18 |
| Localized edema | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Malaise | 2/41 (4.9%) | 2 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Deterioration of general condition | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Cholestasis | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Hepatic cytolysis | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Infections and infestations | ||||||
| Bronchial infection | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Cranial nerve infection | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Kidney infection | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Lung infection | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 1/99 (1%) | 1 |
| Mucosal infection | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Paronychia | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Sepsis | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Urinary tract infection | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 1/99 (1%) | 1 |
| Alkaline phosphatase increased | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 1/99 (1%) | 1 |
| Aspartate aminotransferase increased | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 1/99 (1%) | 1 |
| Blood bilirubin increased | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Electrocardiogram QT corrected interval prolonged | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| GGT increased | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Neutrophil count decreased | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Weight loss | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 1/41 (2.4%) | 1 | 15/171 (8.8%) | 15 | 5/99 (5.1%) | 5 |
| Dehydration | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Hyperglycemia | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Hypokalemia | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Myalgia | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tumor bleeding | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Nervous system disorders | ||||||
| Dysgeusia | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Headache | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 1/99 (1%) | 1 |
| Hypersomnia | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Intracranial hemorrhage | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Ischemia cerebrovascular | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Peripheral sensory neuropathy | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Psychiatric disorders | ||||||
| Mood disorders | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Chronic kidney disease | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Hematuria | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Proteinuria | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Nephrotic syndrome | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 0/41 (0%) | 0 | 7/171 (4.1%) | 7 | 0/99 (0%) | 0 |
| Epistaxis | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Pleural hemorrhage | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Pneumonitis | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Palmar-plantar erythrodysesthesia syndrome | 1/41 (2.4%) | 1 | 2/171 (1.2%) | 2 | 4/99 (4%) | 4 |
| Rash acneiform | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Rash maculo-papular | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Skin ulceration | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Urticaria | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Haemorrhage | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Dermal toxicity | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Skin rash | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Pruritic rash | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 0/41 (0%) | 0 | 3/171 (1.8%) | 3 | 5/99 (5.1%) | 5 |
| Hypotension | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Prospective Cohort | Retrospective Cohort A | Retrospective Cohort B | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/41 (87.8%) | 131/171 (76.6%) | 76/99 (76.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 6/41 (14.6%) | 7 | 16/171 (9.4%) | 16 | 11/99 (11.1%) | 11 |
| Thrombopenia | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 4/99 (4%) | 4 |
| Cardiac disorders | ||||||
| Ventricular tachycardia | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Tinnitus | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Vertigo | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 1/99 (1%) | 1 |
| Endocrine disorders | ||||||
| Hypothyroidism | 2/41 (4.9%) | 2 | 3/171 (1.8%) | 3 | 11/99 (11.1%) | 11 |
| Eye disorders | ||||||
| Conjunctivitis | 0/41 (0%) | 0 | 6/171 (3.5%) | 6 | 0/99 (0%) | 0 |
| Watering eyes | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 2/99 (2%) | 2 |
| Ascites | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Bloating | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Constipation | 4/41 (9.8%) | 5 | 6/171 (3.5%) | 6 | 2/99 (2%) | 2 |
| Diarrhea | 16/41 (39%) | 18 | 32/171 (18.7%) | 32 | 30/99 (30.3%) | 30 |
| Dry mouth | 2/41 (4.9%) | 2 | 2/171 (1.2%) | 2 | 2/99 (2%) | 2 |
| Dyspepsia | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 2/99 (2%) | 2 |
| Gastritis | 0/41 (0%) | 0 | 1/171 (0.6%) | 1 | 4/99 (4%) | 4 |
| Gastroesophageal reflux disease | 1/41 (2.4%) | 1 | 2/171 (1.2%) | 2 | 1/99 (1%) | 1 |
| Gastrointestinal pain | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Hemorrhoids | 0/41 (0%) | 0 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Mucositis oral | 6/41 (14.6%) | 6 | 21/171 (12.3%) | 21 | 15/99 (15.2%) | 15 |
| Nausea | 8/41 (19.5%) | 8 | 6/171 (3.5%) | 6 | 8/99 (8.1%) | 8 |
| Small intestinal obstruction | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Vomiting | 5/41 (12.2%) | 5 | 8/171 (4.7%) | 8 | 1/99 (1%) | 1 |
| Sphincter disorders | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| General disorders | ||||||
| Edema limbs | 1/41 (2.4%) | 1 | 10/171 (5.8%) | 10 | 1/99 (1%) | 1 |
| Fatigue | 27/41 (65.9%) | 27 | 42/171 (24.6%) | 42 | 56/99 (56.6%) | 56 |
| Fever | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 1/99 (1%) | 1 |
| Gait disturbance | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Pain | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 1/99 (1%) | 1 |
| Altered general condition | 2/41 (4.9%) | 2 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Hepatic cytolysis | 3/41 (7.3%) | 3 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Infections and infestations | ||||||
| Bronchial infection | 1/41 (2.4%) | 1 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Lung infection | 1/41 (2.4%) | 1 | 3/171 (1.8%) | 3 | 2/99 (2%) | 2 |
| Mucosal infection | 1/41 (2.4%) | 1 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Sepsis | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Skin infection | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Tooth infection | 1/41 (2.4%) | 1 | 3/171 (1.8%) | 3 | 1/99 (1%) | 1 |
| Urinary tract infection | 3/41 (7.3%) | 4 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Staphylococcal infection | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Dermatitis radiation | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 0/41 (0%) | 0 | 16/171 (9.4%) | 16 | 0/99 (0%) | 0 |
| Alkaline phosphatase increased | 1/41 (2.4%) | 1 | 6/171 (3.5%) | 6 | 0/99 (0%) | 0 |
| Aspartate aminotransferase increased | 0/41 (0%) | 0 | 13/171 (7.6%) | 13 | 1/99 (1%) | 1 |
| Blood bilirubin increased | 2/41 (4.9%) | 3 | 3/171 (1.8%) | 3 | 0/99 (0%) | 0 |
| Cholesterol high | 0/41 (0%) | 0 | 15/171 (8.8%) | 15 | 0/99 (0%) | 0 |
| Creatinine increased | 2/41 (4.9%) | 2 | 5/171 (2.9%) | 5 | 1/99 (1%) | 1 |
| Electrocardiogram QT corrected interval prolonged | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Neutrophil count decreased | 3/41 (7.3%) | 3 | 4/171 (2.3%) | 4 | 3/99 (3%) | 3 |
| Platelet count decreased | 7/41 (17.1%) | 7 | 8/171 (4.7%) | 8 | 10/99 (10.1%) | 10 |
| Weight loss | 3/41 (7.3%) | 3 | 4/171 (2.3%) | 4 | 2/99 (2%) | 2 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 16/41 (39%) | 17 | 19/171 (11.1%) | 19 | 25/99 (25.3%) | 25 |
| Hypercalcemia | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Hyperglycemia | 0/41 (0%) | 0 | 6/171 (3.5%) | 6 | 0/99 (0%) | 0 |
| Hypertriglyceridemia | 0/41 (0%) | 0 | 16/171 (9.4%) | 16 | 0/99 (0%) | 0 |
| Hypocalcemia | 1/41 (2.4%) | 1 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Severe undernutrition | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 3/41 (7.3%) | 3 | 6/171 (3.5%) | 6 | 6/99 (6.1%) | 6 |
| Back pain | 1/41 (2.4%) | 1 | 5/171 (2.9%) | 5 | 2/99 (2%) | 2 |
| Bone pain | 2/41 (4.9%) | 3 | 7/171 (4.1%) | 7 | 0/99 (0%) | 0 |
| Myalgia | 2/41 (4.9%) | 2 | 2/171 (1.2%) | 2 | 2/99 (2%) | 2 |
| Cramps | 3/41 (7.3%) | 3 | 2/171 (1.2%) | 2 | 1/99 (1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Tumor pain | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Nervous system disorders | ||||||
| Dysgeusia | 9/41 (22%) | 10 | 9/171 (5.3%) | 9 | 3/99 (3%) | 3 |
| Headache | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 0/99 (0%) | 0 |
| Memory impairment | 1/41 (2.4%) | 1 | 2/171 (1.2%) | 2 | 0/99 (0%) | 0 |
| Neuralgia | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Paresthesia | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Peripheral sensory neuropathy | 0/41 (0%) | 0 | 0/171 (0%) | 0 | 3/99 (3%) | 3 |
| Agueusia | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Hypoesthesia | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Psychiatric disorders | ||||||
| Insomnia | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Vigilance disorders | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Hematuria | 0/41 (0%) | 0 | 2/171 (1.2%) | 2 | 2/99 (2%) | 2 |
| Urinary tract pain | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 4/41 (9.8%) | 5 | 12/171 (7%) | 12 | 4/99 (4%) | 4 |
| Epistaxis | 3/41 (7.3%) | 3 | 9/171 (5.3%) | 9 | 3/99 (3%) | 3 |
| Voice alteration | 1/41 (2.4%) | 1 | 4/171 (2.3%) | 4 | 6/99 (6.1%) | 6 |
| Rhinorrhea | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 2/99 (2%) | 2 |
| Dry skin | 4/41 (9.8%) | 5 | 7/171 (4.1%) | 7 | 2/99 (2%) | 2 |
| Palmar-plantar erythrodysesthesia syndrome | 6/41 (14.6%) | 6 | 5/171 (2.9%) | 5 | 17/99 (17.2%) | 17 |
| Periorbital edema | 0/41 (0%) | 0 | 4/171 (2.3%) | 4 | 1/99 (1%) | 1 |
| Pruritus | 1/41 (2.4%) | 1 | 6/171 (3.5%) | 6 | 0/99 (0%) | 0 |
| Rash acneiform | 2/41 (4.9%) | 2 | 26/171 (15.2%) | 26 | 1/99 (1%) | 1 |
| Rash maculo-papular | 2/41 (4.9%) | 2 | 2/171 (1.2%) | 2 | 2/99 (2%) | 2 |
| Skin ulceration | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Erythematous lesion | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Skin rash | 1/41 (2.4%) | 1 | 7/171 (4.1%) | 7 | 0/99 (0%) | 0 |
| Cracks | 1/41 (2.4%) | 1 | 1/171 (0.6%) | 1 | 0/99 (0%) | 0 |
| Cutaneous hemorrhage | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 5/41 (12.2%) | 5 | 8/171 (4.7%) | 8 | 15/99 (15.2%) | 15 |
| Hypotension | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Superficial thrombophlebitis | 1/41 (2.4%) | 1 | 0/171 (0%) | 0 | 0/99 (0%) | 0 |
| Thromboembolic event | 0/41 (0%) | 0 | 5/171 (2.9%) | 5 | 1/99 (1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
| Name/Title | Pr Simone Mathoulin-Pelissier |
|---|---|
| Organization | Institut Bergonié |
| Phone | 0556333333 |
| S.Mathoulin@bordeaux.unicancer.fr |
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT02751827
Other Study ID Numbers:
- IB 2015-02
First Posted:
Apr 26, 2016
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2021