Trial Outcomes & Findings for Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy (NCT NCT01222767)
NCT ID: NCT01222767
Last Updated: 2021-10-29
Results Overview
Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either CR or PR according to the RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years
Results posted on
2021-10-29
Participant Flow
A total of 17 patients were included and 16 of them were treated with PM00104 at five investigational sites from the USA (n=3), France and Italy. The patients participated in this study between 22 December 2010 (first consent) and 21 May 2012 (last follow-up). First and last doses were administered on 4 January 2011 and 24 January 2012, respectively
Participant milestones
| Measure |
PM00104
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Received Treatment
|
16
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
PM00104
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Overall Study
Progressive disease
|
13
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Surgical resection
|
1
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PM00104
n=17 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
|
Age, Continuous
|
23 years
n=17 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=17 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=17 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=17 Participants
|
|
ECOG PS
0
|
9 Participants
n=17 Participants
|
|
ECOG PS
1
|
7 Participants
n=17 Participants
|
|
ECOG PS
2
|
1 Participants
n=17 Participants
|
|
Tumor diagnosis
Ewing's bone sarcoma
|
13 Participants
n=17 Participants
|
|
Tumor diagnosis
Extraosseous sarcoma
|
4 Participants
n=17 Participants
|
|
Primary location at diagnosis
Lower extremity
|
7 Participants
n=17 Participants
|
|
Primary location at diagnosis
Trunk/abdominal wall
|
7 Participants
n=17 Participants
|
|
Primary location at diagnosis
Upper extremity
|
1 Participants
n=17 Participants
|
|
Primary location at diagnosis
Unknown
|
2 Participants
n=17 Participants
|
|
Metastatic disease
|
17 Participants
n=17 Participants
|
|
Time from diagnosis to first infusion
|
43.3 months
n=17 Participants
|
|
Time from last disease progression to first infusion
|
0.3 months
n=17 Participants
|
|
Sites of disease at diagnosis
1
|
7 Participants
n=17 Participants
|
|
Sites of disease at diagnosis
2
|
6 Participants
n=17 Participants
|
|
Sites of disease at diagnosis
3
|
3 Participants
n=17 Participants
|
|
Sites of disease at diagnosis
>3
|
1 Participants
n=17 Participants
|
|
Prior radiotherapy
|
14 Participants
n=17 Participants
|
|
Prior Antitumor surgery (palliative or curative)
|
14 Participants
n=17 Participants
|
|
Prior Systemic anticancer therapy
|
17 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 yearsPopulation: One patient never treated
Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either CR or PR according to the RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Outcome measures
| Measure |
PM00104
n=16 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 yearsPopulation: One patient never treated Two patients were non-evaluable for efficacy because they were withdrawn due to toxicity without any tumor assessment after the start of study treatment and were considered as "treatment failures"
Best tumor response was defined as the best response achieved during the study according to RECIST v1.1 CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Outcome measures
| Measure |
PM00104
n=14 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
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Best Tumor Response
SD
|
4 Participants
|
|
Best Tumor Response
PD
|
10 Participants
|
SECONDARY outcome
Timeframe: From the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation, up to 2 yearsPopulation: One patient never treated
Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density
Outcome measures
| Measure |
PM00104
n=16 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Progression-free Survival
|
1.8 months
Interval 0.9 to 3.5
|
SECONDARY outcome
Timeframe: At 3 monthsPopulation: One patient never treated
Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density
Outcome measures
| Measure |
PM00104
n=16 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
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Progression-free Survival at 3 Months
|
28.6 percentage of participants
Interval 4.9 to 52.2
|
SECONDARY outcome
Timeframe: from the first day of treatment to the date of death, up to 2 yearsPopulation: One patient never treated
Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first.
Outcome measures
| Measure |
PM00104
n=16 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
|
|---|---|
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Overall Survival
|
NA months
Median survival could not be calculated because more than half of patients were still living
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: One patient never treated
Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first.
Outcome measures
| Measure |
PM00104
n=16 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
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Overall Survival Rate at 6 Months
|
62.5 percentage of participants
Interval 38.8 to 86.2
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SECONDARY outcome
Timeframe: At 12 monthsPopulation: One patient never treated
Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first.
Outcome measures
| Measure |
PM00104
n=16 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Overall Survival Rate at 12 Months
|
54.7 percentage of participants
Interval 29.5 to 79.9
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SECONDARY outcome
Timeframe: 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1)Population: Fourteen of the 16 patients treated in this study had plasma profiles
Cmax Maximum plasma concentration, directly determined from the experimental data
Outcome measures
| Measure |
PM00104
n=14 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
PM00104 Plasma PK Parameters (Cmax) at First Infusion
|
21.23 μg/l
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1)Population: Fourteen of the 16 patients treated in this study had plasma profiles
AUC Area under the plasma concentration-time curve from time zero to infinity
Outcome measures
| Measure |
PM00104
n=14 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
PM00104 Plasma PK Parameters (AUC) at First Infusion
|
87.06 h*μg/l
Standard Deviation 75.49
|
SECONDARY outcome
Timeframe: 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of second infusion (Day 8)Population: Eleven of the 16 patients treated in this study had plasma profiles at second infusion
Cmax Maximum plasma concentration, directly determined from the experimental data
Outcome measures
| Measure |
PM00104
n=11 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
PM00104 Plasma PK Parameters (Cmax) at Second Infusion
|
22.37 μg/l
Standard Deviation 8.77
|
SECONDARY outcome
Timeframe: 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of second infusion (Day 8)Population: Eleven of the 16 patients treated in this study had plasma profiles at second infusion
AUC Area under the plasma concentration-time curve from time zero to infinity
Outcome measures
| Measure |
PM00104
n=11 Participants
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
PM00104 Plasma PK Parameters (AUC) at Second Infusion
|
69.76 h*μg/l
Standard Deviation 17.69
|
Adverse Events
PM00104
Serious events: 2 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
PM00104
n=16 participants at risk
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
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|---|---|
|
Infections and infestations
Acute sinusitis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
Other adverse events
| Measure |
PM00104
n=16 participants at risk
PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
2/16 • Number of events 4 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.8%
7/16 • Number of events 11 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Cardiac disorders
Palpitations
|
18.8%
3/16 • Number of events 3 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Cardiac disorders
Pericardial effusion
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Cardiac disorders
Tachycardia
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Ear and labyrinth disorders
Ear congestion
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Eye disorders
Eye swelling
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Eye disorders
Myopia
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 3 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 4 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 7 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
General disorders
Chest pain
|
18.8%
3/16 • Number of events 3 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
General disorders
Fatigue
|
43.8%
7/16 • Number of events 10 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
General disorders
Pyrexia
|
37.5%
6/16 • Number of events 6 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Investigations
Breath sounds abnormal
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
2/16 • Number of events 3 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
18.8%
3/16 • Number of events 5 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Nervous system disorders
Depressed level of consciousness
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • Number of events 3 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 10 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • Number of events 4 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.2%
1/16 • Number of events 3 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Vascular disorders
Pallor
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Vascular disorders
Superior vena caval occlusion
|
6.2%
1/16 • Number of events 2 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
|
Vascular disorders
Venous thrombosis
|
6.2%
1/16 • Number of events 1 • From first infusion to study termination, up to 2 years
Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
|
Additional Information
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
Pharma Mar S.A.
Phone: 0034 91846 60 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER