Trial Outcomes & Findings for A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma (NCT NCT00359294)
NCT ID: NCT00359294
Last Updated: 2021-07-28
Results Overview
DLTs were defined as follows: * Hematological adverse events: * Any grade 4 neutropenia (absolute neutrophil count (ANC) \< 0.5 x109/l) for longer than five days; * Any grade 4 neutropenia accompanied by fever (at least 38.5°C); * Any grade 4 neutropenia and sepsis or other severe infection; * Any grade 4 thrombocytopenia. * Any other grade 3/4 non-hematological adverse event (AE) and any increase of cardiac troponin I ≥0.1 ng/ml together with evidence of cardiac damage by electrocardiogram (ECG) or echocardiogram (ECHO), except for untreated nausea/vomiting or hypersensitivity reactions. * Decrease in left ventricular ejection fraction (LVEF) \> 20% compared to the patient's baseline value and/or LVEF \< 50% below normal limits for the institution. * Delay in the initiation of a subsequent dose exceeding two weeks due to drug related AEs
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
During the first cycle (21 days)
Results posted on
2021-07-28
Participant Flow
Twelve patients were enrolled and 11 patients were treated between 9 May 2006 (first consent signed) and 10 September 2008 (last follow-up). The first dose of the first cycle was administered on 15 May 2006 and the last dose of the last cycle was administered on 20 June 2008
Participant milestones
| Measure |
Dose Level I
PM0104: 0.053 mg/m2
|
Dose-level II
PM00104: 0.106 mg/m2
|
Dose-level III
PM00104: 0.212 mg/m2
|
Dose Level IV
PM00104: 0.318 mg/m2
|
Dose Level V
PM0104: 0.475 mg/m2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
Dose Level I
PM0104: 0.053 mg/m2
|
Dose-level II
PM00104: 0.106 mg/m2
|
Dose-level III
PM00104: 0.212 mg/m2
|
Dose Level IV
PM00104: 0.318 mg/m2
|
Dose Level V
PM0104: 0.475 mg/m2
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
1
|
1
|
2
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Not treated
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma
Baseline characteristics by cohort
| Measure |
Dose-level I
n=1 Participants
PM00104: 0.053 mg/m2
|
Dose-level II
n=1 Participants
PM00104: 0.106 mg/m2
|
Dose-level III
n=3 Participants
PM00104: 0.212 mg/m2
|
Dose-level IV
n=3 Participants
PM00104: 0.318 mg/m2
|
Dose-level V
n=3 Participants
PM00104: 0.475 mg/m2
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
56 years
n=7 Participants
|
54 years
n=5 Participants
|
66.0 years
n=4 Participants
|
57 years
n=21 Participants
|
56 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
ECOG PS
PS 0
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
ECOG PS
PS 1
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
8 participants
n=10 Participants
|
|
Primary tumor
Soft tissue sarcoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Primary tumor
Cervix adenocarcinoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Primary tumor
Colorectal adenocarcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Primary tumor
Head and neck carcinoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Primary tumor
Pseudomyxoma peritoneii
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Primary tumor
Unknown origin
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Prior chemotherapy
2-5 lines
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Prior chemotherapy
≥ 6 lines
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Prior Surgery
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Prior radiotherapy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: During the first cycle (21 days)DLTs were defined as follows: * Hematological adverse events: * Any grade 4 neutropenia (absolute neutrophil count (ANC) \< 0.5 x109/l) for longer than five days; * Any grade 4 neutropenia accompanied by fever (at least 38.5°C); * Any grade 4 neutropenia and sepsis or other severe infection; * Any grade 4 thrombocytopenia. * Any other grade 3/4 non-hematological adverse event (AE) and any increase of cardiac troponin I ≥0.1 ng/ml together with evidence of cardiac damage by electrocardiogram (ECG) or echocardiogram (ECHO), except for untreated nausea/vomiting or hypersensitivity reactions. * Decrease in left ventricular ejection fraction (LVEF) \> 20% compared to the patient's baseline value and/or LVEF \< 50% below normal limits for the institution. * Delay in the initiation of a subsequent dose exceeding two weeks due to drug related AEs
Outcome measures
| Measure |
Dose-level I
n=1 Participants
PM00104: 0.053 mg/m2
|
Dose-level II
n=1 Participants
PM00104: 0.106 mg/m2
|
Dose-level III
n=3 Participants
PM00104: 0.212 mg/m2
|
Dose-level IV
n=3 Participants
PM00104: 0.318 mg/m2
|
Dose-level V
n=3 Participants
PM00104: 0.475 mg/m2
|
|---|---|---|---|---|---|
|
Patients With Dose Limiting Toxicities (DLT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: every six weeks while on study, up to 2 yearsPopulation: 11 patients were evaluable for antitumor activity
Best tumor response was defined as the best response achieved during the study according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR): disappearance of all lesions; Partial response (PR): ≥10% decrease in target lesion size or ≥15% decrease in tumor density; Disease progression (PD): ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; Stable disease (SD): none of the CR, PR, or PD criteria met; RECIST,
Outcome measures
| Measure |
Dose-level I
n=1 Participants
PM00104: 0.053 mg/m2
|
Dose-level II
n=1 Participants
PM00104: 0.106 mg/m2
|
Dose-level III
n=3 Participants
PM00104: 0.212 mg/m2
|
Dose-level IV
n=3 Participants
PM00104: 0.318 mg/m2
|
Dose-level V
n=3 Participants
PM00104: 0.475 mg/m2
|
|---|---|---|---|---|---|
|
Overall Best Tumor Response
PD
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Overall Best Tumor Response
SD
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
PM00104
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PM00104
n=11 participants at risk
All patients were to receive treatment for at least one 3-week cycle, which consisted of PM00104 administrations daily for 5 days and all study evaluations up to the next treatment cycle. Cycles were to be repeated every three weeks until disease progression, unacceptable toxicity, intercurrent serious illness, withdrawal of informed consent by the patient, Investigator's opinion, or treatment delay \> 2 weeks. Patients were considered to be on study for the duration of their treatment and for the first 30 days following treatment discontinuation, defined as the day of the last PM00104 administration
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Metabolism and nutrition disorders
Failure to thrive
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Pancreatitis NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Injury, poisoning and procedural complications
Pyrexia (Febrile Nonhaemolytic transfusion reaction)
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
Other adverse events
| Measure |
PM00104
n=11 participants at risk
All patients were to receive treatment for at least one 3-week cycle, which consisted of PM00104 administrations daily for 5 days and all study evaluations up to the next treatment cycle. Cycles were to be repeated every three weeks until disease progression, unacceptable toxicity, intercurrent serious illness, withdrawal of informed consent by the patient, Investigator's opinion, or treatment delay \> 2 weeks. Patients were considered to be on study for the duration of their treatment and for the first 30 days following treatment discontinuation, defined as the day of the last PM00104 administration
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
27.3%
3/11 • Number of events 5 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Metabolism and nutrition disorders
Anorexia
|
63.6%
7/11 • Number of events 16 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11 • Number of events 5 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Reproductive system and breast disorders
Breast mass NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Chest pressure sensation
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Psychiatric disorders
Confusional state
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 8 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Contusion
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Number of events 8 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Metabolism and nutrition disorders
Dehydration
|
27.3%
3/11 • Number of events 6 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Psychiatric disorders
Depression
|
18.2%
2/11 • Number of events 3 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
36.4%
4/11 • Number of events 7 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Renal and urinary disorders
Difficulty in micturition
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Eye disorders
Dry eye NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
27.3%
3/11 • Number of events 4 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Renal and urinary disorders
Dysuria
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Eye disorders
Eyelid ptosis
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Fatigue
|
54.5%
6/11 • Number of events 23 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Flatulence
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Infections and infestations
Groin infection
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Vascular disorders
Haematoma NOS
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Renal and urinary disorders
Haematuria
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Nervous system disorders
Headache NOS
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Infections and infestations
Herpes zoster
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
1/11 • Number of events 3 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Immune system disorders
Hypersensitivity NOS
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypoglycaemia NOS
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
18.2%
2/11 • Number of events 11 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Vascular disorders
Hypotension NOS
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Infections and infestations
Infection NOS
|
18.2%
2/11 • Number of events 3 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Influenza like illness
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Injection site pain
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Injection site reaction NOS
|
54.5%
6/11 • Number of events 14 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Injection site vesicles
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Vascular disorders
Lymphoedema NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11 • Number of events 5 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Nausea
|
72.7%
8/11 • Number of events 19 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Nervous system disorders
Paraesthesia
|
27.3%
3/11 • Number of events 6 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Vascular disorders
Phlebitis NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Pruritus NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Pyrexia
|
36.4%
4/11 • Number of events 6 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Retching
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Immune system disorders
Seasonal allergy
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Skin disorder NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Stomatitis
|
27.3%
3/11 • Number of events 3 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
18.2%
2/11 • Number of events 3 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Cardiac disorders
Tachycardia NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Tenderness NOS
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Vascular disorders
Thrombosis
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Tongue oedema
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Tumour pain
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Renal and urinary disorders
Urethral obstruction
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Renal and urinary disorders
Urinary frequency
|
9.1%
1/11 • Number of events 3 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Infections and infestations
Urinary tract infection NOS
|
18.2%
2/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Renal and urinary disorders
Urine odour abnormal
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Urticaria NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Eye disorders
Visual disturbance NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Nervous system disorders
Visual field defect NOS
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Eye disorders
Vitreous detachment
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Gastrointestinal disorders
Vomiting NOS
|
45.5%
5/11 • Number of events 11 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
General disorders
Weakness
|
9.1%
1/11 • Number of events 2 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Investigations
Weight decreased
|
27.3%
3/11 • Number of events 4 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • From first infusion to study termination, up to 2 years
All patients treated with PM00104 were evaluable for safety
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER