Trial Outcomes & Findings for Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma (NCT NCT01127451)
NCT ID: NCT01127451
Last Updated: 2022-04-13
Results Overview
irORR was defined as the percentage of participants with best confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]). irORR was assessed by immune-related response criteria (irRC). Per irRC criteria, irCR was defined as complete disappearance of all tumor lesions, whether measurable or not, and no new lesions. irPR was defined as decrease in tumor burden by 50 percent (%) or greater (confirmed in 2 observations at least 4 weeks apart).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
From the start of treatment up to 1 year 6 months
Results posted on
2022-04-13
Participant Flow
Participants took part in the study at 12 investigative sites in the United States from 22 June 2010 to 07 April 2015.
A total of 75 participants were randomized and treated.
Participant milestones
| Measure |
Denileukin Diftitox on Days 1 to 4
Participants received Denileukin Diftitox 12 microgram per kilogram per day (mcg/kg/day) on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
32
|
|
Overall Study
Safety Analysis Set
|
43
|
32
|
|
Overall Study
Modified Intent-to-Treat (MITT)
|
42
|
32
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
32
|
Reasons for withdrawal
| Measure |
Denileukin Diftitox on Days 1 to 4
Participants received Denileukin Diftitox 12 microgram per kilogram per day (mcg/kg/day) on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Overall Study
Other
|
2
|
1
|
|
Overall Study
Completed 1 Year Follow-up after last dose of study drug
|
14
|
12
|
|
Overall Study
Death
|
22
|
17
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Administrative Reason by Sponsor
|
2
|
2
|
Baseline Characteristics
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Denileukin Diftitox on Days 1 to 4
n=43 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
68 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment up to 1 year 6 monthsPopulation: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation.
irORR was defined as the percentage of participants with best confirmed response (immune-related complete response \[irCR\] or immune-related partial response \[irPR\]). irORR was assessed by immune-related response criteria (irRC). Per irRC criteria, irCR was defined as complete disappearance of all tumor lesions, whether measurable or not, and no new lesions. irPR was defined as decrease in tumor burden by 50 percent (%) or greater (confirmed in 2 observations at least 4 weeks apart).
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=42 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Percentage of Participants With Immune-related Overall Response Rate (irORR)
|
9.5 percentage of participants
Interval 3.3 to 20.4
|
3.1 percentage of participants
Interval 0.1 to 13.9
|
SECONDARY outcome
Timeframe: From the start of treatment to the date of first documentation of irPD, or date of death, whichever occurred first up to 1 year 6 monthsPopulation: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation.
The PFS was defined as time from start of study treatment until immune-related progressive disease (irPD) or death. If the participant did not progress, the participant was censored at the date of last tumor assessment, known alive, or until starting a next line of therapy, whichever occurred first. PFS was assessed by irRC. irPD was defined as at least 25% increase in tumor burden relative to nadir (at any single time point) in 2 consecutive observations at least 4 weeks apart. The PFS was estimated using the Kaplan-Meier method. The median time (weeks) and the corresponding 90% confidence interval were estimated for each treatment group are reported.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=42 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
12.1 weeks
Interval 11.6 to 14.0
|
12.1 weeks
Interval 11.6 to 13.0
|
SECONDARY outcome
Timeframe: Month 6Population: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation.
The PFS was defined as time from start of study treatment until irPD or death. If the participant did not progress, the participant was censored at the date of last tumor assessment, known alive, or until starting a next line of therapy, whichever occurred first. PFS was assessed by irRC. irPD was defined as at least 25% increase in tumor burden relative to nadir (at any single time point) in 2 consecutive observations at least 4 weeks apart. Percentage of participants with PFS at month 6 are reported and was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=42 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Percentage of Participants With PFS at Month 6
|
28.5 percentage of participants
Interval 15.2 to 43.3
|
23.0 percentage of participants
Interval 9.7 to 39.6
|
SECONDARY outcome
Timeframe: From date of the first demonstration of irCR or irPR until the date of first demonstration of PD, date of death, or withdrawal from study up to 1 year 6 monthsPopulation: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation. Here "overall number of participants analyzed" signifies participants who had confirmed irCR or irPR.
Duration of response was defined as the time from date of the first assessment demonstrating an irCR or irPR to date of the first assessment demonstrating progressive disease (PD), death, or withdrawal from study. In the absence of confirmation of death or PD, duration of response was censored at the last date of follow-up when the participant was known to be alive and have maintained a response. Duration of response was assessed by irRC. Per irRC criteria, irCR was defined as complete disappearance of all tumor lesions, whether measurable or not, and no new lesions. irPR was defined as decrease in tumor burden by 50% or greater (confirmed in 2 observations at least 4 weeks apart). The duration of response was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=4 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=1 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Duration of Response
|
32.9 weeks
Interval 26.6 to 49.6
|
54.3 weeks
Interval 54.3 to 54.3
|
SECONDARY outcome
Timeframe: From the date of randomization until the date of death up to 1 year 6 monthsPopulation: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation.
The OS was defined as the time from the date of randomization until the date of death. OS was estimated by Kaplan-Meier method. The median time (weeks) and the corresponding 90% confidence interval were estimated for each treatment group were reported.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=42 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Overall Survival (OS)
|
51.1 weeks
Interval 37.1 to 113.6
|
54.3 weeks
Interval 30.7 to 77.1
|
SECONDARY outcome
Timeframe: From the date of randomization up to 1 yearPopulation: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation.
The OS was defined as the time from the date of randomization until the date of death. OS at 1 year was estimated by Kaplan-Meier method. OS at 1 year was measured as the percentage of participants still alive at 1 year from the date of randomization.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=42 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Percentage of Participants With OS at 1 Year
|
42.8 percentage of participants
Interval 21.9 to 62.3
|
50.0 percentage of participants
Interval 29.0 to 67.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure.
Treg (regulatory T cells) from peripheral blood and tumor tissues were assessed for best immune-related response. Assessment of Treg cells was done by immunohistochemical (IHC) analysis. Change from baseline in CD4+CD127-/loCD25+CD152- (surface marker expressed in Treg cells) expression pattern, by treatment and immune-related response are reported.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=39 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=29 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Change From Baseline in CD4+CD127-/loCD25+CD152- Cells Expression Pattern at Weeks 12
At Baseline
|
135.9 cells per microliter
Standard Deviation 86.17
|
184.9 cells per microliter
Standard Deviation 114.90
|
|
Change From Baseline in CD4+CD127-/loCD25+CD152- Cells Expression Pattern at Weeks 12
Change at Week 12
|
6.4 cells per microliter
Standard Deviation 69.63
|
-46.1 cells per microliter
Standard Deviation 74.72
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: MITT included all participants enrolled and randomized to treatment and had an efficacy evaluation. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable at specified timepoints for this outcome measure.
Treg (regulatory T cells) from peripheral blood and tumor tissues were assessed for best immune-related response. Assessment of Treg cells was done by IHC analysis. Change from baseline in CD4+CD127-/loCD25hiCD152- (surface marker expressed in Treg cells) expression pattern, by treatment and immune-related response are reported.
Outcome measures
| Measure |
Denileukin Diftitox on Days 1 to 4
n=39 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=29 Participants
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Change From Baseline in CD4+CD127-/loCD25hiCD152- Cells Expression Pattern at Weeks 12
At Baseline
|
34.8 cells per microliter
Standard Deviation 16.58
|
40.0 cells per microliter
Standard Deviation 21.01
|
|
Change From Baseline in CD4+CD127-/loCD25hiCD152- Cells Expression Pattern at Weeks 12
Change at Week 12
|
-8.0 cells per microliter
Standard Deviation 19.22
|
-13.3 cells per microliter
Standard Deviation 13.37
|
Adverse Events
Denileukin Diftitox on Days 1 to 4
Serious events: 15 serious events
Other events: 43 other events
Deaths: 22 deaths
Denileukin Diftitox on Days 1, 8, and 15
Serious events: 8 serious events
Other events: 9 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Denileukin Diftitox on Days 1 to 4
n=43 participants at risk
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 participants at risk
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Cardiac disorders
Atrial Tachycardia
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Cardiac disorders
Coronary Artery Disease
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Colitis
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Asthenia
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Chest Pain
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Fatigue
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Generalised Oedema
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Pain
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Pyrexia
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Infections and infestations
Endocarditis Bacterial
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Psychiatric disorders
Confusional State
|
4.7%
2/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Vascular disorders
Hypotension
|
4.7%
2/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.3%
1/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
Other adverse events
| Measure |
Denileukin Diftitox on Days 1 to 4
n=43 participants at risk
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1 to 4 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
Denileukin Diftitox on Days 1, 8, and 15
n=32 participants at risk
Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8 and 15 of 21-day treatment cycle for a total of 4 cycles (12 weeks) or until unacceptable toxicity or rapid and life-threatening progressive disease.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.3%
4/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Eye disorders
Vitreous floaters
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Constipation
|
14.0%
6/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
7/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Nausea
|
55.8%
24/43 • From first dose of study drug up to approximately 1 year 6 months
|
12.5%
4/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
9/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Asthenia
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Chills
|
46.5%
20/43 • From first dose of study drug up to approximately 1 year 6 months
|
9.4%
3/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Fatigue
|
58.1%
25/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Generalised oedema
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Influenza like illness
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Pain
|
9.3%
4/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
General disorders
Pyrexia
|
14.0%
6/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.6%
5/43 • From first dose of study drug up to approximately 1 year 6 months
|
6.2%
2/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Investigations
Alanine aminotransferase increased
|
27.9%
12/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
23.3%
10/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.9%
9/43 • From first dose of study drug up to approximately 1 year 6 months
|
9.4%
3/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
20.9%
9/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
4/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
5/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43 • From first dose of study drug up to approximately 1 year 6 months
|
6.2%
2/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Nervous system disorders
Dysgeusia
|
9.3%
4/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Nervous system disorders
Headache
|
16.3%
7/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Nervous system disorders
Restless legs syndrome
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Psychiatric disorders
Anxiety
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Psychiatric disorders
Insomnia
|
18.6%
8/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.0%
6/43 • From first dose of study drug up to approximately 1 year 6 months
|
3.1%
1/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.0%
3/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.6%
5/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
|
Vascular disorders
Hypotension
|
14.0%
6/43 • From first dose of study drug up to approximately 1 year 6 months
|
0.00%
0/32 • From first dose of study drug up to approximately 1 year 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place