Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma (NCT NCT04313608)
NCT ID: NCT04313608
Last Updated: 2024-03-25
Results Overview
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Baseline - 90 days after last dose of study treatment
Results posted on
2024-03-25
Participant Flow
Participant milestones
| Measure |
Arm A: Glofit-GemOx
Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
|
Arm B: Mosun-GemOx
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
6
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
3
|
Reasons for withdrawal
| Measure |
Arm A: Glofit-GemOx
Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
|
Arm B: Mosun-GemOx
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Overall Study
Death
|
12
|
3
|
Baseline Characteristics
A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 18.3 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - 90 days after last dose of study treatmentAn adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Number of Deaths Due to Adverse Events (AEs)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline - 90 days after last dose of study treatmentAn adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Number of Treatment Discontinuations Due to AE
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline - 90 days after last dose of study treatmentAn adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Proportion of Participants With Serious Adverse Events (SAEs)
|
70.6 Proportion expressed as percentage
|
66.7 Proportion expressed as percentage
|
PRIMARY outcome
Timeframe: Baseline - 90 days after last dose of study treatmentSeverity of CRS was determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria, in which Grade 1 as fever (≥38.0°C) with or without other symptoms; Grade 2 as fever with hypotension not requiring vasopressors and/or hypoxia requiring the use of oxygen (low-flow); and Grade 3 as fever with hypotension requiring one vasopressor with or without vasopressin and/or hypoxia requiring the use of oxygen (high-flow).
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity
Grade 1
|
29.4 Proportion expressed as percentage
|
16.7 Proportion expressed as percentage
|
|
Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity
Grade 2
|
11.8 Proportion expressed as percentage
|
0 Proportion expressed as percentage
|
|
Proportion of Participants With Cytokine Release Syndrome (CRS) by Grade of Severity
Grade 3
|
5.9 Proportion expressed as percentage
|
0 Proportion expressed as percentage
|
SECONDARY outcome
Timeframe: Up to approximately 16 monthsOutcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs
AEs leading to treatment discontinuation
|
5.9 percentage of participants
|
16.7 percentage of participants
|
|
Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs
AEs leading to dose modification or interruption
|
29.4 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 16 monthsPer the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), with higher scores indicating more extensive disease.
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria
|
23.5 percentage
Interval 6.81 to 49.9
|
50.0 percentage
Interval 11.81 to 88.19
|
SECONDARY outcome
Timeframe: Up to approximately 16 monthsPer the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), while a PR = partial metabolic response with a score of 4 or 5 on 5PS with higher scores indicating more extensive disease.
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
n=6 Participants
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria
|
35.3 Proportion expressed as percentage
|
50.0 Proportion expressed as percentage
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 and Cycle 2 Day 1Population: The pharmacokinetic population consisted of all participants that received at least one dose of glofitamab or mosunetuzumab and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Arm A: Glofit-GemOx
n=17 Participants
Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).
|
Arm B: Mosun-GemOx
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Glofitamab
20 hours post infusion Cycle 2 Day 1
|
6.5 ug/mL
Interval 4.4 to 11.2
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
44 hours post infusion Cycle 2 Day 1
|
3.8 ug/mL
Interval 3.2 to 4.3
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
Pre-infusion Cycle 1 Day 8
|
0 ug/mL
Interval 0.0 to 0.0
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
Within 30 mins post infusion Cycle 1 Day 8
|
0.6 ug/mL
Interval 0.3 to 1.7
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
12 hours post infusion Cycle 1 Day 8
|
0.6 ug/mL
Interval 0.1 to 0.9
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
24 hours post infusion Cycle 1 Day 8
|
0.5 ug/mL
Interval 0.1 to 0.8
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
48 hours post infusion Cycle 1 Day 8
|
0.3 ug/mL
Interval 0.0 to 0.4
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
Pre-infusion Cycle 2 Day 1
|
0.8 ug/mL
Interval 0.1 to 1.3
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
Within 30 minutes post infusion Cycle 2 Day 1
|
9 ug/mL
Interval 6.8 to 17.7
|
—
|
|
Maximum Serum Concentration (Cmax) of Glofitamab
6 hours post infusion Cycle 2 Day 1
|
7.8 ug/mL
Interval 5.5 to 13.1
|
—
|
Adverse Events
Arm A: Glofit-GemOx
Serious events: 12 serious events
Other events: 17 other events
Deaths: 1 deaths
Arm B: Mosun-GemOx
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Glofit-GemOx
n=17 participants at risk
Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
|
Arm B: Mosun-GemOx
n=6 participants at risk
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Colitis
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
General disorders
Asthenia
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
General disorders
Pyrexia
|
35.3%
6/17 • Number of events 6 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Immune system disorders
Cytokine release syndrome
|
11.8%
2/17 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Neutropenic sepsis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Sepsis
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Wound infection
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Orthostatic hypotension
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
Other adverse events
| Measure |
Arm A: Glofit-GemOx
n=17 participants at risk
Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)
|
Arm B: Mosun-GemOx
n=6 participants at risk
Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.3%
6/17 • Number of events 15 • Baseline - 90 days after the final dose of study treatment
|
50.0%
3/6 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.5%
4/17 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 8 • Baseline - 90 days after the final dose of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.5%
4/17 • Number of events 6 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Eye disorders
Blepharitis
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Eye disorders
Eye pain
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Eye disorders
Vision blurred
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Anal haemorrhage
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Colitis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
23.5%
4/17 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
50.0%
3/6 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
35.3%
6/17 • Number of events 6 • Baseline - 90 days after the final dose of study treatment
|
83.3%
5/6 • Number of events 10 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
23.5%
4/17 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
66.7%
4/6 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
General disorders
Chest pain
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
General disorders
Fatigue
|
23.5%
4/17 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
66.7%
4/6 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
|
General disorders
Performance status decreased
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Immune system disorders
Cytokine release syndrome
|
41.2%
7/17 • Number of events 14 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Immune system disorders
Seasonal allergy
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Candida infection
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
External ear cellulitis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Oral candidiasis
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
50.0%
3/6 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Injury
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Blood creatinine increased
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Liver function test abnormal
|
23.5%
4/17 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Neutrophil count decreased
|
17.6%
3/17 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Platelet count decreased
|
23.5%
4/17 • Number of events 7 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Investigations
Weight decreased
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
35.3%
6/17 • Number of events 9 • Baseline - 90 days after the final dose of study treatment
|
66.7%
4/6 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
23.5%
4/17 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
66.7%
4/6 • Number of events 9 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Intention tremor
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Lethargy
|
17.6%
3/17 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Neuropathy peripheral
|
35.3%
6/17 • Number of events 7 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.6%
3/17 • Number of events 4 • Baseline - 90 days after the final dose of study treatment
|
50.0%
3/6 • Number of events 3 • Baseline - 90 days after the final dose of study treatment
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Flushing
|
11.8%
2/17 • Number of events 5 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Superficial vein thrombosis
|
11.8%
2/17 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
16.7%
1/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/17 • Baseline - 90 days after the final dose of study treatment
|
33.3%
2/6 • Number of events 2 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Thrombosis
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
|
Vascular disorders
Vasospasm
|
5.9%
1/17 • Number of events 1 • Baseline - 90 days after the final dose of study treatment
|
0.00%
0/6 • Baseline - 90 days after the final dose of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER