NIMES-ROC: Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
Sponsor
PharmaMar (Industry)
Overall Status
Completed
CT.gov ID
NCT02825420
Collaborator
(none)
220
65
49.7
3.4
0.1
Study Details
Study Description
Brief Summary
Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
220 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug
Actual Study Start Date
:
Jul 28, 2015
Actual Primary Completion Date
:
Sep 18, 2019
Actual Study Completion Date
:
Sep 18, 2019
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival [From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)]
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Progression Free Survival by Prior Antiangiogenic Treatment [From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)]
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Progression Free Survival by BRCA1/2 Status [From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)]
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Progression Free Survival by Platinum Sensitivity [From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)]
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Secondary Outcome Measures
- Best Tumor Response [From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)]
Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- Best Response by Prior Antiangiogenic Treatment [From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)]
Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- Overall Survival [From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)]
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
- Overall Survival by Prior Antiangiogenic Treatment [From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)]
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
- Overall Survival by BRCA1/2 Status [From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)]
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
- Overall Survival by Platinum Sensitivity [From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)]
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
- Change From Baseline to Best Post-baseline ECOG Performance Status Score [Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)]
Eastern Cooperative Oncology Group performance status (ECOG): 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 or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 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
- Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment [Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)]
Eastern Cooperative Oncology Group performance status (ECOG): 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 or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Women aged 18 years or older.
-
Presence of platinum-sensitive relapsed ovarian cancer.
-
Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.
-
Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.
-
Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | O.L.V. Aalst | Aalst | Flandes | Belgium | 164-9300 |
| 2 | AZ Maria Middelares | Gent | Flandes | Belgium | 1026-9000 |
| 3 | Centre Hospitalier de Jolimont | La Louviere | Henao | Belgium | 7100 |
| 4 | CHU Ambroise-Paré | Mons | Henao | Belgium | 02-7000 |
| 5 | Centre Hospitalier de Wallonie Picarde | Tournai | Henao | Belgium | 807500 |
| 6 | CHIREC - Cancer Institute | Bruxelles | Belgium | 32-1180 | |
| 7 | Centre d'Oncologie et de Radiothérapie du Parc | Dijon | Borgoña | France | 21000 |
| 8 | Clinique Saint Jean | Toulon | Provence | France | 83000 |
| 9 | Institut d'Oncologie Hauts-de-Seine Nord | Neuilly sur Seine | Seine | France | |
| 10 | Clinique Victor Hugo - Centre Jean Bernard | Le Mans | Sharte | France | 72000 |
| 11 | Clinique de l'Europe | Amiens | France | 80000 | |
| 12 | Medipole de Savoie | Challes Les Eaux | France | 73190 | |
| 13 | Oncologie médicale du Val d'Oise | Osny | France | 95520 | |
| 14 | Hôpital Saint Louis | Paris | France | 75010 | |
| 15 | Strasbourg Oncologie Libérale Centre de radiothérapie | Strasbourg | France | 67000 | |
| 16 | Onkologie Westerstede | Westerstede | Ammerland | Germany | 26655 |
| 17 | Klinikum Kempten | Kempten | Baviera | Germany | 87439 |
| 18 | Städtisches Klinikum | Solingen | Düsseldorf | Germany | 42653 |
| 19 | Klinikum Darmstadt Frauenklinik | Darmstadt | Hesse | Germany | 64283 |
| 20 | Brustzentrum | Wetzlar | Hesse | Germany | 35578 |
| 21 | Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin | Homburg/Saar | Homburg | Germany | 66424 |
| 22 | Onkologische Schwerpunktpraxis | Dresden | Sajonia | Germany | 1307 |
| 23 | Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie | Georgsmarienhutte | Sajonia | Germany | 49124 |
| 24 | Klinikum St. Marien Amberg | Amberg | Germany | 92224 | |
| 25 | Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde | Arnsberg | Germany | 59759 | |
| 26 | Onkologische Gemeinschaftspraxis | Bottrop | Germany | 46236 | |
| 27 | Städt. Klinik Dortmund, Frauenklinik | Dortmund | Germany | 44137 | |
| 28 | Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH | München | Germany | 80804 | |
| 29 | Praxis Dr. Rene Schubert | Scheibenberg | Germany | 09481 | |
| 30 | Kreiskrankenhaus Torgau | Torgau | Germany | 04860 | |
| 31 | Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula | Monserrato | Cerdeña | Italy | 09042 |
| 32 | IRCCS Casa Sollievo Della Sofferenza | San Giovanni Rotondo | Foggia | Italy | 71013 |
| 33 | Centro Riferimento Oncologico di Aviano | Aviano | Pordenone | Italy | 33081 |
| 34 | Ospedale S.Maria d. Misericordia | Bergamo | Savona | Italy | 24047 |
| 35 | Ospedale Cardinal Massaia | Asti | Italy | 14100 | |
| 36 | Istituto Tumori Giovanni Paolo II IRCCS | Bari | Italy | 70124 | |
| 37 | Azienda Ospedaliera Gaetano Rummo | Benevento | Italy | 82100 | |
| 38 | A. O. Papa Giovanni XXIII | Bergamo | Italy | 24127 | |
| 39 | Ospedale S. Anna | Como | Italy | 22020 | |
| 40 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50134 | |
| 41 | A.O. Sacco | Milano | Italy | 20157 | |
| 42 | Istituto Nazionale Tumori IRCCS Pascale | Napoli | Italy | 80131 | |
| 43 | A.O.U. di Parma | Parma | Italy | 43126 | |
| 44 | Policlinico Universitario Agostino Gemelli Università Cattolica di Roma | Roma | Italy | 00168 | |
| 45 | Ospedale Gradenigo | Torino | Italy | 10153 | |
| 46 | Ospedale Cà Foncello | Treviso | Italy | 31100 | |
| 47 | Complejo Hospitalario de Jaén | Jaén | Jaen | Spain | 23007 |
| 48 | Hospital Doctor Negrín | Las Palmas de Gran Canaria | Las Palmas | Spain | 35010 |
| 49 | Hospital de León | Leon | León | Spain | 28040 |
| 50 | Hospital Infanta Cristina | Parla | Madrid | Spain | 06080 |
| 51 | Hospital Xeral-Cíes de Vigo | Vigo | Pontevedra | Spain | 36204 |
| 52 | Hospital Universitario de La Laguna | San Cristóbal de La Laguna | Santa Cruz De Tenerife | Spain | 38320 |
| 53 | Hospital de Basurto | Bilbao | Vizcaya | Spain | 48013 |
| 54 | Hospital de Galdakao | Galdakao | Vizcaya | Spain | 48960 |
| 55 | Hospital Sant Pau | Barcelona | Spain | 08026 | |
| 56 | Hospital de Reus | Barcelona | Spain | 43204 | |
| 57 | Complejo Hospitalario de La Coruña | La Coruña | Spain | 15006 | |
| 58 | MD Anderson | Madrid | Spain | 28033 | |
| 59 | Hospital Ramón y Cajal | Madrid | Spain | 28034 | |
| 60 | Hospital Clínico San Carlos | Madrid | Spain | 28040 | |
| 61 | Hospital Virgen de la Arrixaca | Murcia | Spain | 30120 | |
| 62 | Hospital Son Llatzer | Palma de Mallorca | Spain | 07198 | |
| 63 | Hospital Virgen Macarena | Sevilla | Spain | 41071 | |
| 64 | Instituto Valenciano de Oncología | Valencia | Spain | 46009 | |
| 65 | Hospital Clínico Universitario Lozano Blesa | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- PharmaMar
Investigators
- Study Chair: María José Pontes, PharmaMar
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
PharmaMar
ClinicalTrials.gov Identifier:
NCT02825420
Other Study ID Numbers:
- ET-D-031-14
First Posted:
Jul 7, 2016
Last Update Posted:
Oct 29, 2021
Last Verified:
Jul 1, 2021
Study Results
Participant Flow
| Recruitment Details | A total of 220 patients treated according to standard local clinical practice in 57 sites across Italy, Spain, Germany, France, and Belgium have been enrolled in the study. The first patient was included in the study on 28 July 2015. Data were collected between 26 January 2015, date of first patient trabectedin administration (prior treatment before inclusion in the study) and 18 September 2019, date of last patient last visit. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics |
|---|---|---|
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| Period Title: Overall Study | ||
| STARTED | 131 | 89 |
| COMPLETED | 88 | 72 |
| NOT COMPLETED | 43 | 17 |
Baseline Characteristics
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics | Total |
|---|---|---|---|
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Total of all reporting groups |
| Overall Participants | 129 | 89 | 218 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
75
58.1%
|
54
60.7%
|
129
59.2%
|
| >=65 years |
54
41.9%
|
35
39.3%
|
89
40.8%
|
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
61.0
|
61.0
|
61.0
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
129
100%
|
89
100%
|
218
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (Count of Participants) | |||
| Belgium |
10
7.8%
|
2
2.2%
|
12
5.5%
|
| Italy |
57
44.2%
|
37
41.6%
|
94
43.1%
|
| France |
9
7%
|
5
5.6%
|
14
6.4%
|
| Germany |
16
12.4%
|
2
2.2%
|
18
8.3%
|
| Spain |
39
30.2%
|
43
48.3%
|
82
37.6%
|
| Weight (Kg) [Median (Full Range) ] | |||
| Median (Full Range) [Kg] |
64.0
|
68.0
|
65.0
|
| Height (cm) [Median (Full Range) ] | |||
| Median (Full Range) [cm] |
160
|
158
|
160
|
| Calculated body surface area (m^2) [Median (Full Range) ] | |||
| Median (Full Range) [m^2] |
1.7
|
1.7
|
1.7
|
| Investigator reported body surface area (m^2) [Median (Full Range) ] | |||
| Median (Full Range) [m^2] |
1.6
|
1.7
|
1.7
|
| Tumor grade at diagnosis (Count of Participants) | |||
| High grade |
95
73.6%
|
61
68.5%
|
156
71.6%
|
| Intermediate grade |
9
7%
|
5
5.6%
|
14
6.4%
|
| Low grade |
6
4.7%
|
6
6.7%
|
12
5.5%
|
| Not done/not reported/unknown |
19
14.7%
|
17
19.1%
|
36
16.5%
|
| Histopathology at initial ovarian cancer diagnosis (Count of Participants) | |||
| Papillary/serous |
97
75.2%
|
60
67.4%
|
157
72%
|
| Endometroid |
6
4.7%
|
8
9%
|
14
6.4%
|
| Clear cell carcinoma |
6
4.7%
|
4
4.5%
|
10
4.6%
|
| Peritoneal carcinoma |
6
4.7%
|
3
3.4%
|
9
4.1%
|
| Mixed epithelial tumour |
4
3.1%
|
1
1.1%
|
5
2.3%
|
| Mucinous |
2
1.6%
|
1
1.1%
|
3
1.4%
|
| Undifferentiated carcinoma |
2
1.6%
|
1
1.1%
|
3
1.4%
|
| Fallopian tube carcinoma |
0
0%
|
2
2.2%
|
2
0.9%
|
| Transitional carcinoma (brenner) |
0
0%
|
1
1.1%
|
1
0.5%
|
| Transitional carcinoma (no brenner) |
0
0%
|
1
1.1%
|
1
0.5%
|
| Unknown |
6
4.7%
|
7
7.9%
|
13
6%
|
| Platinum sensitivity (Count of Participants) | |||
| Partially Platinum Sensitive |
80
62%
|
47
52.8%
|
127
58.3%
|
| Fully Platinum Sensitive |
48
37.2%
|
41
46.1%
|
89
40.8%
|
| Missing |
1
0.8%
|
1
1.1%
|
2
0.9%
|
| BRCA 1/2 status tested (Count of Participants) | |||
| Positive |
15
11.6%
|
19
21.3%
|
34
15.6%
|
| Negative |
68
52.7%
|
32
36%
|
100
45.9%
|
| Unknown |
1
0.8%
|
0
0%
|
1
0.5%
|
| Not tested |
45
34.9%
|
38
42.7%
|
83
38.1%
|
| ECOG performance status (Count of Participants) | |||
| PS 0 |
63
48.8%
|
45
50.6%
|
108
49.5%
|
| PS 1 |
41
31.8%
|
15
16.9%
|
56
25.7%
|
| PS 2 |
3
2.3%
|
3
3.4%
|
6
2.8%
|
| Missing |
22
17.1%
|
26
29.2%
|
48
22%
|
| Prior surgery (Count of Participants) | |||
| Count of Participants [Participants] |
118
91.5%
|
81
91%
|
199
91.3%
|
| Surgery residual disease (Count of Participants) | |||
| Count of Participants [Participants] |
58
45%
|
26
29.2%
|
84
38.5%
|
| Prior radiotherapy (Count of Participants) | |||
| Count of Participants [Participants] |
4
3.1%
|
3
3.4%
|
7
3.2%
|
| Prior chemotherapy (Count of Participants) | |||
| Count of Participants [Participants] |
129
100%
|
88
98.9%
|
217
99.5%
|
| Number of prior chemotherapy lines (Count of Participants) | |||
| None |
0
0%
|
1
1.1%
|
1
0.5%
|
| 1 prior line |
22
17.1%
|
37
41.6%
|
59
27.1%
|
| 2 prior lines |
48
37.2%
|
23
25.8%
|
71
32.6%
|
| 3 prior lines |
32
24.8%
|
11
12.4%
|
43
19.7%
|
| 4-8 prior lines |
27
20.9%
|
17
19.1%
|
44
20.2%
|
| Best response to prior therapy regimen (Count of Participants) | |||
| Complete Response |
24
18.6%
|
31
34.8%
|
55
25.2%
|
| Partial Response |
31
24%
|
23
25.8%
|
54
24.8%
|
| Stable Disease |
36
27.9%
|
12
13.5%
|
48
22%
|
| Disease recurrence/Progression disease |
26
20.2%
|
6
6.7%
|
32
14.7%
|
| Not Evaluable/Not done/Unknown |
12
9.3%
|
17
19.1%
|
29
13.3%
|
Outcome Measures
| Title | Progression-Free Survival |
|---|---|
| Description | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Time Frame | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Full Analysis Set |
|---|---|
| Arm/Group Description | The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD. |
| Measure Participants | 218 |
| Median (95% Confidence Interval) [months] |
9.46
|
| Title | Progression Free Survival by Prior Antiangiogenic Treatment |
|---|---|
| Description | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Time Frame | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics |
|---|---|---|
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| Measure Participants | 129 | 89 |
| Median (95% Confidence Interval) [months] |
7.59
|
12.45
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Full Analysis Set, No Prior Use of Antiangiogenics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Progression Free Survival by BRCA1/2 Status |
|---|---|
| Description | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Time Frame | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Positive BRCA | Negative |
|---|---|---|
| Arm/Group Description | Patients with Positive BRCA | Patients with Negative BRCA |
| Measure Participants | 34 | 100 |
| Median (95% Confidence Interval) [months] |
9.23
|
8.97
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Full Analysis Set, No Prior Use of Antiangiogenics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.58 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Progression Free Survival by Platinum Sensitivity |
|---|---|
| Description | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Time Frame | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fully Platinum Sensitivity | Partially Platinum Sensitivity |
|---|---|---|
| Arm/Group Description | Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin. | Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin. |
| Measure Participants | 89 | 127 |
| Median (95% Confidence Interval) [months] |
9.26
|
9.46
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Full Analysis Set, No Prior Use of Antiangiogenics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Best Tumor Response |
|---|---|
| Description | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
| Time Frame | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Full Analysis Set |
|---|---|
| Arm/Group Description | The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD. |
| Measure Participants | 218 |
| Complete response |
24
18.6%
|
| Partial response |
57
44.2%
|
| Stable disease |
59
45.7%
|
| Progressive disease |
62
48.1%
|
| Not evaluable/Not done |
16
12.4%
|
| Title | Best Response by Prior Antiangiogenic Treatment |
|---|---|
| Description | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
| Time Frame | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics |
|---|---|---|
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| Measure Participants | 129 | 89 |
| Progressive disease |
46
35.7%
|
16
18%
|
| Stable disease |
32
24.8%
|
27
30.3%
|
| Partial response |
27
20.9%
|
30
33.7%
|
| Complete response |
11
8.5%
|
13
14.6%
|
| Not evaluable/Not done |
13
10.1%
|
3
3.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Full Analysis Set, No Prior Use of Antiangiogenics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Overall Survival |
|---|---|
| Description | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Time Frame | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Full Analysis Set |
|---|---|
| Arm/Group Description | The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD. |
| Measure Participants | 218 |
| Median (95% Confidence Interval) [months] |
23.56
|
| Title | Overall Survival by Prior Antiangiogenic Treatment |
|---|---|
| Description | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Time Frame | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics |
|---|---|---|
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| Measure Participants | 129 | 89 |
| Median (95% Confidence Interval) [months] |
21.85
|
26.28
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Full Analysis Set, No Prior Use of Antiangiogenics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.048 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Overall Survival by BRCA1/2 Status |
|---|---|
| Description | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Time Frame | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Positive BRCA | Negative |
|---|---|---|
| Arm/Group Description | Patients with Positive BRCA | Patients with Negative BRCA |
| Measure Participants | 34 | 100 |
| Median (95% Confidence Interval) [months] |
23.56
|
21.85
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Full Analysis Set, No Prior Use of Antiangiogenics |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.51 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Overall Survival by Platinum Sensitivity |
|---|---|
| Description | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Time Frame | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fully Platinum Sensitivity | Partially Platinum Sensitivity |
|---|---|---|
| Arm/Group Description | Cancer that responds Fully to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin. | Cancer that responds Partially to treatment with anticancer drugs that contain the metal platinum, such as cisplatin and carboplatin. |
| Measure Participants | 89 | 127 |
| Median (95% Confidence Interval) [months] |
23.56
|
26.05
|
| Title | Change From Baseline to Best Post-baseline ECOG Performance Status Score |
|---|---|
| Description | Eastern Cooperative Oncology Group performance status (ECOG): 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 or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 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 |
| Time Frame | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Full Analysis Set |
|---|---|
| Arm/Group Description | The full analysis set consisted of all the patients enrolled into the study and who had at least one administration of T + PLD. |
| Measure Participants | 218 |
| Less than 0 (improvement) |
24
18.6%
|
| 0 (no change) |
125
96.9%
|
| More than 0 to 2 (deterioration) |
14
10.9%
|
| Missing |
55
42.6%
|
| Title | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment |
|---|---|
| Description | Eastern Cooperative Oncology Group performance status (ECOG): 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 or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 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 |
| Time Frame | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics |
|---|---|---|
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib |
| Measure Participants | 129 | 89 |
| Less than 0 (improvement) |
14
10.9%
|
10
11.2%
|
| 0 (no change) |
83
64.3%
|
42
47.2%
|
| More than 0 to 2 (deterioration) |
5
3.9%
|
9
10.1%
|
| Missing |
27
20.9%
|
28
31.5%
|
Adverse Events
| Time Frame | From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Two patients were excluded from the safety set because of missing PLD treatment data | |||
| Arm/Group Title | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics | ||
| Arm/Group Description | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | ||
All Cause Mortality |
||||
| Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/129 (23.3%) | 12/89 (13.5%) | ||
Serious Adverse Events |
||||
| Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 23/129 (17.8%) | 14/89 (15.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/129 (2.3%) | 3 | 1/89 (1.1%) | 1 |
| Febrile neutropenia | 4/129 (3.1%) | 4 | 4/89 (4.5%) | 4 |
| Neutropenia | 5/129 (3.9%) | 7 | 4/89 (4.5%) | 4 |
| Pancytopenia | 2/129 (1.6%) | 2 | 1/89 (1.1%) | 1 |
| Thrombocytopenia | 4/129 (3.1%) | 5 | 1/89 (1.1%) | 1 |
| Leukopenia | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Dysphagia | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Gastrointestinal obstruction | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Nausea | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Oesophagitis | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Retching | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Vomiting | 4/129 (3.1%) | 6 | 1/89 (1.1%) | 1 |
| Abdominal pain | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Enteritis | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Intestinal obstruction | 0/129 (0%) | 0 | 1/89 (1.1%) | 3 |
| General disorders | ||||
| Asthenia | 1/129 (0.8%) | 1 | 1/89 (1.1%) | 1 |
| Disease progression | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Fatigue | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Oedema | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Pyrexia | 2/129 (1.6%) | 2 | 0/89 (0%) | 0 |
| Immune system disorders | ||||
| Drug hypersensitivity | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Infections and infestations | ||||
| Device related infection | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Escherichia infection | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Infusion site infection | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Pneumocystis jirovecii pneumonia | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Pneumonia | 2/129 (1.6%) | 2 | 0/89 (0%) | 0 |
| Respiratory tract infection | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Sepsis | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Upper respiratory tract infection | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Urosepsis | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Bacteraemia | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Clostridium difficile infection | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Investigations | ||||
| Blood alkaline phosphatase increased | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Blood electrolytes decreased | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Platelet count decreased | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Transaminases increased | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/129 (0.8%) | 2 | 0/89 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Hepatic cancer metastatic | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebral haemorrhage | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Convulsion | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Psychiatric disorders | ||||
| Mood altered | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Renal and urinary disorders | ||||
| Azotaemia | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Renal failure | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Renal failure acute | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dysphonia | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Dyspnoea | 4/129 (3.1%) | 4 | 0/89 (0%) | 0 |
| Pleural effusion | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Pulmonary embolism | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Pyoderma gangrenosum | 1/129 (0.8%) | 1 | 0/89 (0%) | 0 |
| Surgical and medical procedures | ||||
| Off label use | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
| Vascular disorders | ||||
| Embolism | 0/129 (0%) | 0 | 1/89 (1.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 106/129 (82.2%) | 78/89 (87.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 45/129 (34.9%) | 99 | 25/89 (28.1%) | 48 |
| Leukopenia | 18/129 (14%) | 36 | 7/89 (7.9%) | 22 |
| Neutropenia | 57/129 (44.2%) | 162 | 46/89 (51.7%) | 152 |
| Thrombocytopenia | 22/129 (17.1%) | 34 | 6/89 (6.7%) | 14 |
| Gastrointestinal disorders | ||||
| Constipation | 15/129 (11.6%) | 22 | 12/89 (13.5%) | 15 |
| Diarrhoea | 10/129 (7.8%) | 12 | 8/89 (9%) | 10 |
| Nausea | 39/129 (30.2%) | 63 | 26/89 (29.2%) | 36 |
| Stomatitis | 5/129 (3.9%) | 5 | 5/89 (5.6%) | 6 |
| Vomiting | 30/129 (23.3%) | 42 | 15/89 (16.9%) | 19 |
| General disorders | ||||
| Asthenia | 35/129 (27.1%) | 64 | 37/89 (41.6%) | 61 |
| Fatigue | 11/129 (8.5%) | 11 | 5/89 (5.6%) | 6 |
| Mucosal inflammation | 10/129 (7.8%) | 16 | 15/89 (16.9%) | 22 |
| Investigations | ||||
| Neutrophil count decreased | 9/129 (7%) | 30 | 7/89 (7.9%) | 13 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 13/129 (10.1%) | 21 | 8/89 (9%) | 8 |
| Skin and subcutaneous tissue disorders | ||||
| Palmar-plantar erythrodysaesthesia syndrome | 4/129 (3.1%) | 6 | 12/89 (13.5%) | 17 |
| Skin hyperpigmentation | 1/129 (0.8%) | 1 | 5/89 (5.6%) | 5 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
Results Point of Contact
| Name/Title | Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit. |
|---|---|
| Organization | Pharma Mar S.A. |
| Phone | 0034 91846 60 00 |
| clinicaltrials@pharmamar.com |
Responsible Party:
PharmaMar
ClinicalTrials.gov Identifier:
NCT02825420
Other Study ID Numbers:
- ET-D-031-14
First Posted:
Jul 7, 2016
Last Update Posted:
Oct 29, 2021
Last Verified:
Jul 1, 2021