An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trabectedin Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. |
Drug: Trabectedin
Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
| Active Comparator: Doxorubicin plus Ifosfamide Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
Drug: Doxorubicin
Doxorubicin 60 or 75 mg/m^2 will be given intravenously every 3 weeks until disease progression.
Drug: Ifosfamide
Ifosfamide 6 to 9 g/m^2 will be given intravenously every 3 weeks until disease progression.
|
Outcome Measures
Primary Outcome Measures
- Progression - Free Survival (PFS) [Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months]
The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Secondary Outcome Measures
- 6-month Progression - Free Survival [6 months]
Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.
- Percentage of Participants With Objective Response [Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months]
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
- Overall Survival [Baseline up to End of Study (an average of 4 years)]
Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
- Duration of Response (DOR) [Up to 20 months]
The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma
-
Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2
-
Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan [MUGA]
-
Measurable disease as defined by the radiological (computed tomography [CT] scan and magnetic resonance imaging [MRI]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines
Exclusion Criteria:
-
Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators
-
Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available
-
Brain metastases and/or leptomeningeal metastases, even if treated
-
Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods
-
History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Santa Monica | California | United States | ||
| 2 | Boston | Massachusetts | United States | ||
| 3 | Albuquerque | New Mexico | United States | ||
| 4 | Philadelphia | Pennsylvania | United States | ||
| 5 | Houston | Texas | United States | ||
| 6 | Salt Lake City | Utah | United States | ||
| 7 | Boreaux | France | |||
| 8 | Lille | France | |||
| 9 | Lyon | France | |||
| 10 | Paris | France | |||
| 11 | Villejuif | France | |||
| 12 | Bad Saarow | Germany | |||
| 13 | Köln | Germany | |||
| 14 | Mannheim | Germany | |||
| 15 | Barcelona | Spain | |||
| 16 | Palma De Mallorca N/A | Spain | |||
| 17 | Valencia N/A | Spain | |||
| 18 | Edinburgh | United Kingdom | |||
| 19 | Glasgow | United Kingdom | |||
| 20 | London | United Kingdom | |||
| 21 | Manchester | United Kingdom |
Sponsors and Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- PharmaMar
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR015769
- ET-C-002-07
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| Period Title: Overall Study | ||
| STARTED | 61 | 60 |
| Treated | 61 | 57 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 61 | 60 |
Baseline Characteristics
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide | Total |
|---|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. | Total of all reporting groups |
| Overall Participants | 61 | 60 | 121 |
| Age, Customized (participants) [Number] | |||
| >=18 to <=49 years |
33
54.1%
|
30
50%
|
63
52.1%
|
| >=50 to <=65 years |
19
31.1%
|
21
35%
|
40
33.1%
|
| >=65 years |
9
14.8%
|
9
15%
|
18
14.9%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
41%
|
22
36.7%
|
47
38.8%
|
| Male |
36
59%
|
38
63.3%
|
74
61.2%
|
Outcome Measures
| Title | Progression - Free Survival (PFS) |
|---|---|
| Description | The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. |
| Time Frame | Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS) |
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| Measure Participants | 51 | 37 |
| Median (95% Confidence Interval) [months] |
19.6
|
8.3
|
| Title | 6-month Progression - Free Survival |
|---|---|
| Description | Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. |
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| Measure Participants | 51 | 37 |
| Number (95% Confidence Interval) [percentage of participants] |
66.7
109.3%
|
78.3
130.5%
|
| Title | Percentage of Participants With Objective Response |
|---|---|
| Description | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. |
| Time Frame | Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. |
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| Measure Participants | 51 | 37 |
| Number (95% Confidence Interval) [percentage of participants] |
5.9
9.7%
|
27.0
45%
|
| Title | Overall Survival |
|---|---|
| Description | Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date. |
| Time Frame | Baseline up to End of Study (an average of 4 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. |
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| Measure Participants | 51 | 37 |
| Median (95% Confidence Interval) [months] |
46.6
|
33.5
|
| Title | Duration of Response (DOR) |
|---|---|
| Description | The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions. |
| Time Frame | Up to 20 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. |
| Measure Participants | 3 | 10 |
| Median (95% Confidence Interval) [days] |
NA
|
NA
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Trabectedin | Doxorubicin Plus Ifosfamide | ||
| Arm/Group Description | Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. | Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression. | ||
All Cause Mortality |
||||
| Trabectedin | Doxorubicin Plus Ifosfamide | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Trabectedin | Doxorubicin Plus Ifosfamide | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/61 (39.3%) | 16/57 (28.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 2/61 (3.3%) | 1/57 (1.8%) | ||
| Febrile neutropenia | 1/61 (1.6%) | 7/57 (12.3%) | ||
| Leukopenia | 0/61 (0%) | 1/57 (1.8%) | ||
| Neutropenia | 2/61 (3.3%) | 2/57 (3.5%) | ||
| Thrombocytopenia | 2/61 (3.3%) | 1/57 (1.8%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/61 (0%) | 3/57 (5.3%) | ||
| Duodenal perforation | 1/61 (1.6%) | 0/57 (0%) | ||
| Nausea | 1/61 (1.6%) | 0/57 (0%) | ||
| Vomiting | 2/61 (3.3%) | 0/57 (0%) | ||
| General disorders | ||||
| Chest discomfort | 1/61 (1.6%) | 0/57 (0%) | ||
| Chest pain | 0/61 (0%) | 1/57 (1.8%) | ||
| Drug withdrawal syndrome | 1/61 (1.6%) | 0/57 (0%) | ||
| Fatigue | 0/61 (0%) | 1/57 (1.8%) | ||
| Hypothermia | 1/61 (1.6%) | 0/57 (0%) | ||
| Injection site extravasation | 3/61 (4.9%) | 0/57 (0%) | ||
| Pain | 2/61 (3.3%) | 0/57 (0%) | ||
| Pyrexia | 3/61 (4.9%) | 2/57 (3.5%) | ||
| Hepatobiliary disorders | ||||
| Liver injury | 1/61 (1.6%) | 0/57 (0%) | ||
| Hepatocellular injury | 1/61 (1.6%) | 0/57 (0%) | ||
| Infections and infestations | ||||
| Bacteremia | 1/61 (1.6%) | 0/57 (0%) | ||
| Bronchitis viral | 1/61 (1.6%) | 0/57 (0%) | ||
| Catheter related infection | 4/61 (6.6%) | 0/57 (0%) | ||
| Device related infection | 3/61 (4.9%) | 0/57 (0%) | ||
| Erysipelas | 1/61 (1.6%) | 0/57 (0%) | ||
| Infusion site infection | 1/61 (1.6%) | 0/57 (0%) | ||
| Lower respiratory tract infection | 1/61 (1.6%) | 0/57 (0%) | ||
| Pneumococcal bacteremia | 0/61 (0%) | 1/57 (1.8%) | ||
| Pneumonia | 1/61 (1.6%) | 2/57 (3.5%) | ||
| Respiratory tract infection | 1/61 (1.6%) | 0/57 (0%) | ||
| Rhinitis | 0/61 (0%) | 1/57 (1.8%) | ||
| Sepsis | 1/61 (1.6%) | 0/57 (0%) | ||
| Investigations | ||||
| Blood CPK increased | 1/61 (1.6%) | 0/57 (0%) | ||
| Blood creatinine increased | 0/61 (0%) | 1/57 (1.8%) | ||
| Liver function test abnormal | 1/61 (1.6%) | 0/57 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperglycemia | 0/61 (0%) | 1/57 (1.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/61 (0%) | 1/57 (1.8%) | ||
| Muscular weakness | 1/61 (1.6%) | 0/57 (0%) | ||
| Myalgia | 1/61 (1.6%) | 0/57 (0%) | ||
| Rhabdomyolysis | 1/61 (1.6%) | 0/57 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumor pain | 1/61 (1.6%) | 0/57 (0%) | ||
| Myelodysplastic syndrome | 2/61 (3.3%) | 0/57 (0%) | ||
| Nervous system disorders | ||||
| Dyspraxia | 1/61 (1.6%) | 0/57 (0%) | ||
| Syncope vasovagal | 0/61 (0%) | 1/57 (1.8%) | ||
| Psychiatric disorders | ||||
| Mental disorder | 1/61 (1.6%) | 1/57 (1.8%) | ||
| Renal and urinary disorders | ||||
| Renal impairment | 1/61 (1.6%) | 0/57 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 1/61 (1.6%) | 0/57 (0%) | ||
| Pulmonary embolism | 1/61 (1.6%) | 2/57 (3.5%) | ||
| Respiratory failure | 1/61 (1.6%) | 0/57 (0%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 2/61 (3.3%) | 0/57 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Trabectedin | Doxorubicin Plus Ifosfamide | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 55/61 (90.2%) | 52/57 (91.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 11/61 (18%) | 13/57 (22.8%) | ||
| Neutropenia | 29/61 (47.5%) | 15/57 (26.3%) | ||
| Thrombocytopenia | 9/61 (14.8%) | 2/57 (3.5%) | ||
| Cardiac disorders | ||||
| Tachycardia | 3/61 (4.9%) | 4/57 (7%) | ||
| Eye disorders | ||||
| Eye irritation | 0/61 (0%) | 3/57 (5.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 4/61 (6.6%) | 2/57 (3.5%) | ||
| Abdominal pain | 8/61 (13.1%) | 7/57 (12.3%) | ||
| Abdominal pain upper | 8/61 (13.1%) | 5/57 (8.8%) | ||
| Constipation | 27/61 (44.3%) | 16/57 (28.1%) | ||
| Diarrhoea | 15/61 (24.6%) | 15/57 (26.3%) | ||
| Dry mouth | 2/61 (3.3%) | 3/57 (5.3%) | ||
| Dyspepsia | 8/61 (13.1%) | 7/57 (12.3%) | ||
| Haemorrhoids | 1/61 (1.6%) | 4/57 (7%) | ||
| Nausea | 46/61 (75.4%) | 40/57 (70.2%) | ||
| Oral pain | 0/61 (0%) | 10/57 (17.5%) | ||
| Stomatitis | 1/61 (1.6%) | 6/57 (10.5%) | ||
| Vomiting | 29/61 (47.5%) | 16/57 (28.1%) | ||
| General disorders | ||||
| Chest pain | 3/61 (4.9%) | 3/57 (5.3%) | ||
| Fatigue | 45/61 (73.8%) | 42/57 (73.7%) | ||
| Mass | 10/61 (16.4%) | 5/57 (8.8%) | ||
| Mucosal inflammation | 4/61 (6.6%) | 15/57 (26.3%) | ||
| Oedema peripheral | 18/61 (29.5%) | 6/57 (10.5%) | ||
| Pain | 2/61 (3.3%) | 3/57 (5.3%) | ||
| Pyrexia | 10/61 (16.4%) | 11/57 (19.3%) | ||
| Infections and infestations | ||||
| Candidiasis | 0/61 (0%) | 3/57 (5.3%) | ||
| Catheter related infection | 4/61 (6.6%) | 0/57 (0%) | ||
| Urinary tract infection | 2/61 (3.3%) | 3/57 (5.3%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 19/61 (31.1%) | 1/57 (1.8%) | ||
| Aspartate aminotransferase increased | 9/61 (14.8%) | 0/57 (0%) | ||
| Blood alkaline phosphataseincreased | 6/61 (9.8%) | 0/57 (0%) | ||
| Blood creatine phosphokinase increased | 4/61 (6.6%) | 1/57 (1.8%) | ||
| Gamma-glutamyltransferase increased | 6/61 (9.8%) | 0/57 (0%) | ||
| Weight decreased | 4/61 (6.6%) | 8/57 (14%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 20/61 (32.8%) | 15/57 (26.3%) | ||
| Dehydration | 3/61 (4.9%) | 4/57 (7%) | ||
| Hypocalcaemia | 3/61 (4.9%) | 4/57 (7%) | ||
| Hypokalaemia | 2/61 (3.3%) | 4/57 (7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 5/61 (8.2%) | 7/57 (12.3%) | ||
| Back pain | 8/61 (13.1%) | 9/57 (15.8%) | ||
| Joint range of motion decreased | 4/61 (6.6%) | 1/57 (1.8%) | ||
| Muscle spasms | 2/61 (3.3%) | 3/57 (5.3%) | ||
| Musculoskeletal pain | 4/61 (6.6%) | 1/57 (1.8%) | ||
| Myalgia | 7/61 (11.5%) | 2/57 (3.5%) | ||
| Pain in extremity | 6/61 (9.8%) | 3/57 (5.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumour pain | 34/61 (55.7%) | 33/57 (57.9%) | ||
| Nervous system disorders | ||||
| Dizziness | 5/61 (8.2%) | 7/57 (12.3%) | ||
| Dysgeusia | 4/61 (6.6%) | 6/57 (10.5%) | ||
| Headache | 13/61 (21.3%) | 14/57 (24.6%) | ||
| Neuropathy peripheral | 4/61 (6.6%) | 0/57 (0%) | ||
| Paraesthesia | 2/61 (3.3%) | 3/57 (5.3%) | ||
| Tremor | 1/61 (1.6%) | 3/57 (5.3%) | ||
| Psychiatric disorders | ||||
| Anxiety | 6/61 (9.8%) | 4/57 (7%) | ||
| Insomnia | 12/61 (19.7%) | 6/57 (10.5%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 10/61 (16.4%) | 10/57 (17.5%) | ||
| Dyspnoea | 12/61 (19.7%) | 6/57 (10.5%) | ||
| Hiccups | 0/61 (0%) | 4/57 (7%) | ||
| Pharyngolaryngeal pain | 5/61 (8.2%) | 2/57 (3.5%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 0/61 (0%) | 3/57 (5.3%) | ||
| Alopecia | 2/61 (3.3%) | 25/57 (43.9%) | ||
| Rash | 4/61 (6.6%) | 6/57 (10.5%) | ||
| Scar | 4/61 (6.6%) | 2/57 (3.5%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 4/61 (6.6%) | 0/57 (0%) | ||
| Hypertension | 7/61 (11.5%) | 0/57 (0%) | ||
| Hypotension | 2/61 (3.3%) | 3/57 (5.3%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Before Investigators of this study publicly disclose information, PharmaMar must be provided with at least 60 days to review and approve disclosure in order to ensure that confidential and proprietary data are protected. If PharmaMar determines that patentable patient matter is disclosed in the proposed disclosure, the latter shall be withheld for period of time considered convenient.
Results Point of Contact
| Name/Title | Medical Specialist, Clinical Oncology |
|---|---|
| Organization | PharmaMar SA Av de los Reyes 1, Poligono Industrial La Mina 28770 Colmenar Viejo, Madrid, Spain |
| Phone | +34 91 646-6087 |
- CR015769
- ET-C-002-07