Trial Outcomes & Findings for A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma (NCT NCT02783599)
NCT ID: NCT02783599
Last Updated: 2019-08-12
Results Overview
Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Baseline, End of Cycle 1 (21 days)
Results posted on
2019-08-12
Participant Flow
Participants are considered to have completed the study if they completed one cycle of monotherapy and all 6 cycles of combination therapy.
Participant milestones
| Measure |
Olaratumab + Doxorubicin
Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.
Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.
Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
Received At Least One Dose of Study Drug
|
51
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Olaratumab + Doxorubicin
Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.
Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.
Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.
|
|---|---|
|
Overall Study
Progressive disease
|
23
|
|
Overall Study
Surgical Resection
|
10
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
All participants who received at least one dose of study drug and had evaluable blood samples for CTCs at baseline.
Baseline characteristics by cohort
| Measure |
Olaratumab + Doxorubicin
n=51 Participants
Cycle 1: olaratumab 20 mg/kg administered intravenously IV on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.
Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.
Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=51 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=51 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=51 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=51 Participants
|
|
Region of Enrollment
Spain
|
25 Participants
n=51 Participants
|
|
Circulating Tumor Cells (CTC)
Traditional CTC
|
2.183 CTC per milliliter
STANDARD_DEVIATION 2.631 • n=35 Participants • All participants who received at least one dose of study drug and had evaluable blood samples for CTCs at baseline.
|
|
Circulating Tumor Cells (CTC)
All Population CTC
|
2.446 CTC per milliliter
STANDARD_DEVIATION 2.797 • n=35 Participants • All participants who received at least one dose of study drug and had evaluable blood samples for CTCs at baseline.
|
|
Platelet-Derived Growth Factor Receptor Alpha (PGDFRα ) and PGDFR Beta (β)
PGDFRα
|
301.68 relative gene expression units
STANDARD_DEVIATION 570.79 • n=37 Participants • All participants who received at least one dose of study drug and had evaluable tissue samples at baseline.
|
|
Platelet-Derived Growth Factor Receptor Alpha (PGDFRα ) and PGDFR Beta (β)
PGDFRβ
|
812.49 relative gene expression units
STANDARD_DEVIATION 1260.23 • n=37 Participants • All participants who received at least one dose of study drug and had evaluable tissue samples at baseline.
|
|
PDGF Canonical Ligands -A, -B, -C, -D
PGDF-A
|
12.90 relative gene expression units
STANDARD_DEVIATION 18.46 • n=37 Participants • All participants who received at least one dose of study drug and had evaluable tissue samples at baseline.
|
|
PDGF Canonical Ligands -A, -B, -C, -D
PDGF-B
|
230.62 relative gene expression units
STANDARD_DEVIATION 1151.87 • n=37 Participants • All participants who received at least one dose of study drug and had evaluable tissue samples at baseline.
|
|
PDGF Canonical Ligands -A, -B, -C, -D
PDGF-C
|
227.68 relative gene expression units
STANDARD_DEVIATION 447.56 • n=37 Participants • All participants who received at least one dose of study drug and had evaluable tissue samples at baseline.
|
|
PDGF Canonical Ligands -A, -B, -C, -D
PDGF-D
|
33.22 relative gene expression units
STANDARD_DEVIATION 69.99 • n=37 Participants • All participants who received at least one dose of study drug and had evaluable tissue samples at baseline.
|
PRIMARY outcome
Timeframe: Baseline, End of Cycle 1 (21 days)Population: All participants who received one cycle of study drug and had evaluable blood samples for CTCs at baseline and post-olaratumab monotherapy.
Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.
Outcome measures
| Measure |
Olaratumab
n=35 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood
Traditional CTCs
|
846.93 percent change
Standard Deviation 3260.60
|
|
Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood
All Population CTCs
|
820.11 percent change
Standard Deviation 3263.41
|
PRIMARY outcome
Timeframe: Baseline, End of Cycle 1 (21 days)Population: All participants who received at least one dose of study drug and had evaluable tissue samples at baseline and post-olaratumab monotherapy.
Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα.
Outcome measures
| Measure |
Olaratumab
n=37 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue
PDGF Receptor α
|
6162.86 percent change in gene expression
Standard Deviation 32383.49
|
|
Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue
PDGF Receptor β
|
1246.25 percent change in gene expression
Standard Deviation 7024.82
|
PRIMARY outcome
Timeframe: Baseline, End of Cycle 1 (21 days)Population: All participants who received at least one dose of study drug and had evaluable baseline tissue samples at baseline and post-olaratumab monotherapy.
PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β.
Outcome measures
| Measure |
Olaratumab
n=37 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
Canonical Ligand PDGF - A
|
189.37 percent change in gene expression
Standard Deviation 672.91
|
|
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
Canonical Ligand PDGF - B
|
602.01 percent change in gene expression
Standard Deviation 2798.92
|
|
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
Canonical Ligand PDGF - C
|
1107.45 percent change in gene expression
Standard Deviation 6053.12
|
|
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
Canonical Ligand PDGF - D
|
2630.36 percent change in gene expression
Standard Deviation 14425.92
|
SECONDARY outcome
Timeframe: Baseline to Objective Progression or Death from Any Cause (Up to 18 Months)Population: All participants who received at least one dose of study drug.
Progression-free survival (PFS) is defined as the time from the date of first study dose to the first date of radiologic disease progression or death due to any cause. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Progression Free Survival (PFS)
|
2.86 months
Interval 1.41 to 9.72
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 18 Months)Population: All participants who received at least one dose of study drug.
Overall Response Rate (ORR) is defined as the percentage of participants achieving a best overall response of either Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. The best overall response is the best response from the start of the treatment until progressive disease (PD)/recurrence.
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 18 Months)Population: All participants who received at least one dose of study drug.
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD. Participants who do not have any post-baseline tumor response assessments for any reason are considered non-responders and are included in the denominator when calculating the response rate.
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR
|
52.9 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 through Cycle 7 (Up to 6 Months)Population: All participants who received at least one dose of study drug.
Resectability rate is obtained when the total number of participants with resectable tumors is divided by the total number of participants. Resectability of a tumor is determined by the surgeon and multi-disciplinary team and dependent on tumor stage and the participants coexisting medical conditions.
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Percentage of Participants With Resectable Tumors (Resectability Rate)
|
35.3 percentage of participants
Interval 22.4306 to 49.9318
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusionPopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Summary of Cmax of olaratumab monotherapy on Cycle 1 Day 1 and Day 8
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy
Cycle 1 Day 1
|
510 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 22
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy
Cycle 1 Day 8
|
661 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusionPopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Cmax of olaratumab Cycles 2 and 3 Day 1 and 8 of a 21-day cycle.
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Cycle 2 Day 1
|
624 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 26
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Cycle 2 Day 8
|
711 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 28
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Cycle 3 Day 1
|
521 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 30
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Cycle 3 Day 8
|
601 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months)Population: All participants who received at least one dose of study drug.
A participant is counted as positive if they had at least one anti-olaratumab antibody positive result during the study.
Outcome measures
| Measure |
Olaratumab
n=51 Participants
Olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 of Cycle 1.
|
|---|---|
|
Number of Participants With Anti-Olaratumab Antibodies
|
1 Participants
|
Adverse Events
Olaratumab + Doxorubicin
Serious events: 22 serious events
Other events: 50 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Olaratumab + Doxorubicin
n=51 participants at risk
Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.
Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1.
Cycle 3-7: olaratumab15mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.6%
9/51 • Number of events 11 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiopulmonary failure
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Anal abscess
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • Number of events 2 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
3.9%
2/51 • Number of events 2 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Guillain-barre syndrome
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/51 • Number of events 1 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Olaratumab + Doxorubicin
n=51 participants at risk
Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin.
Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1.
Cycle 3-7: olaratumab15mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.6%
11/51 • Number of events 22 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.6%
10/51 • Number of events 15 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.7%
7/51 • Number of events 10 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
5/51 • Number of events 7 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
39.2%
20/51 • Number of events 27 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
12/51 • Number of events 17 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
6/51 • Number of events 8 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
7.8%
4/51 • Number of events 5 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
52.9%
27/51 • Number of events 48 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
43.1%
22/51 • Number of events 33 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
12/51 • Number of events 14 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
25.5%
13/51 • Number of events 30 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
7.8%
4/51 • Number of events 4 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
47.1%
24/51 • Number of events 38 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
13.7%
7/51 • Number of events 8 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
17.6%
9/51 • Number of events 13 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.9%
3/51 • Number of events 7 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.8%
4/51 • Number of events 5 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
21.6%
11/51 • Number of events 17 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
7.8%
4/51 • Number of events 7 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
17.6%
9/51 • Number of events 13 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
17/51 • Number of events 21 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
3/51 • Number of events 5 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
3/51 • Number of events 7 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
6/51 • Number of events 6 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.7%
8/51 • Number of events 10 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
4/51 • Number of events 4 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.8%
4/51 • Number of events 4 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
17.6%
9/51 • Number of events 11 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
11.8%
6/51 • Number of events 8 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
15.7%
8/51 • Number of events 9 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.8%
6/51 • Number of events 8 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.7%
7/51 • Number of events 7 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.4%
16/51 • Number of events 17 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
3/51 • Number of events 3 • Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60