Trial Outcomes & Findings for Durvalumab in HIV-1 Patients With Solid Tumors (NCT NCT03094286)
NCT ID: NCT03094286
Last Updated: 2024-06-24
Results Overview
To explore the feasibility of durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg in solid tumors in HIV-1-infected patients The best overall response is a result of a combination of tumor responses in target and nontarget lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From the first dose until last follow up, assessed up to 24 month
Results posted on
2024-06-24
Participant Flow
Between April 2017 and July 2018, a total of 20 patients were enrolled in the study from 7 different sites.
Screening details: Histologically advanced/metatasic lung cancer, head and neck cancer, cervical cancer, melanoma, anal cancer, pancreatic cancer, gastrio-esophageal cancer, triple negative breast cancer, bladder or renal cancer, Cholangiocarcinoma, Kaposi sarcoma, lymphomas, ovarian cancer or Merkel cell carcinoma. HIV infection. Undetectable viral load at last test
Participant milestones
| Measure |
Experimental Arm
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Distribution of time on treatment (months) by PD-L1 A total of 15 patients has PD-L1 evaluated
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Age, Continuous
|
53.50 years
STANDARD_DEVIATION 10.50 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=20 Participants
|
|
ECOG
ECOG 0-1
|
19 participants
n=20 Participants
|
|
ECOG
ECOG 2
|
1 participants
n=20 Participants
|
|
Smoking status
Former smoker
|
9 participants
n=20 Participants
|
|
Smoking status
Never smoker
|
2 participants
n=20 Participants
|
|
Smoking status
Smoker
|
9 participants
n=20 Participants
|
|
Type of Cancer
Anal
|
2 participants
n=20 Participants
|
|
Type of Cancer
Bladder
|
1 participants
n=20 Participants
|
|
Type of Cancer
Melanoma
|
2 participants
n=20 Participants
|
|
Type of Cancer
NSCLC
|
14 participants
n=20 Participants
|
|
Type of Cancer
SCLC
|
1 participants
n=20 Participants
|
|
LungCancer(Y/N)
Yes
|
15 participants
n=20 Participants
|
|
LungCancer(Y/N)
No
|
5 participants
n=20 Participants
|
|
Lung cancer type
NSCLC EGFR-, ALK-
|
14 participants
n=20 Participants
|
|
Lung cancer type
SCLC
|
1 participants
n=20 Participants
|
|
Lung cancer type
Other
|
5 participants
n=20 Participants
|
|
NSCLC histology
Adenocarcinoma
|
8 participants
n=20 Participants
|
|
NSCLC histology
Squamous
|
3 participants
n=20 Participants
|
|
NSCLC histology
NOS/Undifferenciated
|
3 participants
n=20 Participants
|
|
NSCLC histology
N/A
|
6 participants
n=20 Participants
|
|
Metastasis by cancer type
Anal
|
2 participants
n=20 Participants
|
|
Metastasis by cancer type
Bladder
|
1 participants
n=20 Participants
|
|
Metastasis by cancer type
Melanoma
|
2 participants
n=20 Participants
|
|
Metastasis by cancer type
NSCLC
|
14 participants
n=20 Participants
|
|
Metastasis by cancer type
SCLC
|
1 participants
n=20 Participants
|
|
Number of metastatic sites
One
|
5 participants
n=20 Participants
|
|
Number of metastatic sites
Two
|
9 participants
n=20 Participants
|
|
Number of metastatic sites
Three
|
4 participants
n=20 Participants
|
|
Number of metastatic sites
Five
|
2 participants
n=20 Participants
|
|
Basal CD4-count cells/mm3
<200
|
1 participants
n=20 Participants
|
|
Basal CD4-count cells/mm3
200-350
|
8 participants
n=20 Participants
|
|
Basal CD4-count cells/mm3
>350
|
11 participants
n=20 Participants
|
|
HIV-1 group transmission
Heterosexual individuals
|
6 participants
n=20 Participants
|
|
HIV-1 group transmission
MSM
|
6 participants
n=20 Participants
|
|
HIV-1 group transmission
IDUs
|
6 participants
n=20 Participants
|
|
HIV-1 group transmission
Unknown
|
2 participants
n=20 Participants
|
|
Nº of prior systemic therapies
None
|
8 participants
n=20 Participants
|
|
Nº of prior systemic therapies
One
|
4 participants
n=20 Participants
|
|
Nº of prior systemic therapies
Equal or major of Two
|
8 participants
n=20 Participants
|
|
Time since cancer diagnosis
|
1.80 years
STANDARD_DEVIATION 2.80 • n=20 Participants
|
|
Time since HIV diagnosis
|
17.68 years
STANDARD_DEVIATION 10.18 • n=20 Participants
|
|
CD4 at baseline
|
416.95 cells/mm^3
STANDARD_DEVIATION 181.27 • n=20 Participants
|
|
Plasma Viral load at baseline
|
25.39 copies/mL
STANDARD_DEVIATION 15.58 • n=20 Participants
|
|
Treatment duration
|
8.73 Month
STANDARD_DEVIATION 11.57 • n=20 Participants
|
|
Time on treatment and PD-L1
PD-1 Negative
|
5.97 Month
STANDARD_DEVIATION 8.57 • n=11 Participants • Distribution of time on treatment (months) by PD-L1 A total of 15 patients has PD-L1 evaluated
|
|
Time on treatment and PD-L1
PD-1 Positive
|
13.18 Month
STANDARD_DEVIATION 6.14 • n=4 Participants • Distribution of time on treatment (months) by PD-L1 A total of 15 patients has PD-L1 evaluated
|
|
Distribution of time on treatment for patients with Integrase Inhibitors
With Integrase Inhibitors
|
10.90 Months
STANDARD_DEVIATION 13.13 • n=14 Participants • Distribution of time on treatment(months) for patients with/without Integrase Inhibitors in total of all population.
|
|
Distribution of time on treatment for patients with Integrase Inhibitors
Without Integrase Inhibitors
|
3.67 Months
STANDARD_DEVIATION 3.99 • n=6 Participants • Distribution of time on treatment(months) for patients with/without Integrase Inhibitors in total of all population.
|
PRIMARY outcome
Timeframe: From the first dose until last follow up, assessed up to 24 monthTo explore the feasibility of durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg in solid tumors in HIV-1-infected patients The best overall response is a result of a combination of tumor responses in target and nontarget lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Best Response During the Treatment Period
Complete Response
|
1 participants
|
|
Best Response During the Treatment Period
Partial Response
|
3 participants
|
|
Best Response During the Treatment Period
Stable disease
|
5 participants
|
|
Best Response During the Treatment Period
Progression Disease
|
7 participants
|
|
Best Response During the Treatment Period
Not Evaluated
|
4 participants
|
SECONDARY outcome
Timeframe: From the time from first response evaluation to progression or death, assessed up to 24 months.Population: Applying a Kaplan -Meyer model the median duration of response is estimated for each type of cancer
Only patients with best response Stable disease, Partial Response or Complete response during the treatment period are included in the response analysis. Duration of response is the time from response (R) to progression/death (P/D).
Outcome measures
| Measure |
Experimental Arm
n=9 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Duration of Response Global
Anal
|
3.78 Months
Standard Deviation 0
|
|
Duration of Response Global
Melanoma
|
7.39 Months
Standard Deviation 0
|
|
Duration of Response Global
NSCLC
|
3.7 Months
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: From the date of randomization until end of follow up, assessed up to 24 months.Defined as the length of time from the date of diagnose to the date of the first documented progression of disease. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions".A patient who does not progresses neither dies, is censored at the last tumor evaluation where no progression is detected.
Outcome measures
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Progression Free Survival (PFS)
|
2.5 Months
Interval 1.4 to 5.9
|
SECONDARY outcome
Timeframe: From the date of first response until progression or death, assessed up to 24 months.Population: Kaplan Meier Estimated median duration of response- Dolutegravir/ no Dolutegravir patients
Only patients with best response Stable disease, Partial Response or Complete response during the treatment period are included in the response analysis. Duration of response is the time from response (R) to progression/death (P/D).
Outcome measures
| Measure |
Experimental Arm
n=9 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Duration of Response- Dolutegravir/ no Dolutegravir
Dolutegravir
|
27.4 Month
Interval 3.7 to 40.0
|
|
Duration of Response- Dolutegravir/ no Dolutegravir
No Dolutegravir
|
2.8 Month
Interval 1.2 to 3.8
|
SECONDARY outcome
Timeframe: From the date of the first response until progression or death, assessed up to 24 monthsPopulation: Descriptive analysis of response duration - INSTIs (Integrase Inhibitors) or no INSTIs (No Integrase Inhibitors) treated patients
Only patients with best response Stable disease, Partial Response or Complete response during the treatment period are included in the response analysis. Duration of response is the time from response to progression/death.
Outcome measures
| Measure |
Experimental Arm
n=9 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Duration of Response by Treatment With INSTIs or no INSTIs
Integrase Inhibitors
|
11.32 Month
Interval 3.71 to 27.4
|
|
Duration of Response by Treatment With INSTIs or no INSTIs
No Integrase Inhibitors
|
2.10 Month
Interval 1.22 to 3.78
|
SECONDARY outcome
Timeframe: OS is defined as the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored up to 24 monthsPopulation: Kaplan-Meier model- Summary results of OS - Strata PD-L1 patients
Kaplan Meier method will be used to estimate the survival function. OS will be mesure at 24 months.
Outcome measures
| Measure |
Experimental Arm
n=15 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
OS Analysis by PD-L1
PDL-1 negative
|
7.4 Months
Interval 1.2 to 16.3
|
|
OS Analysis by PD-L1
PDL-1 positive
|
18.9 Months
Interval 17.0 to 25.0
|
SECONDARY outcome
Timeframe: From the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored up to 24 monthsPopulation: Kaplan-Meier model- Summary results of OS- Strata Integrase Inhibitors
OS is defined as the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored at the last contact date up to 24 months.
Outcome measures
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
OS Analysis by Integrase Inhibitors
Integrase Inhibitors
|
11.5 Months
Interval 4.8 to 18.8
|
|
OS Analysis by Integrase Inhibitors
No Integrase Inhibitors
|
6.0 Months
Interval 0.4 to 33.3
|
SECONDARY outcome
Timeframe: From the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored up to 24 monthsPopulation: Kaplan-Meier model- Summary results of OS- Strata patients treated with or without Dolutegravir
OS is defined as the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored up to 24 months
Outcome measures
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
OS Analysis by Dolutegravir
Dolutegravir
|
12.8 Month
Interval 1.0 to 18.8
|
|
OS Analysis by Dolutegravir
No Dolutegravir
|
8.4 Month
Interval 0.4 to 19.1
|
SECONDARY outcome
Timeframe: PFS is defined as the time from the inclusion date to the progression or death, due to any cause, up to 24 months patient who does not progresses neither dies, is censored at the last tumor evaluation where no progression is detected.Population: Summary results Strata by PD-L1 results in cancer patients
Progression Free Survival defined as the length of time from the date of diagnosis to the date of the first documented progression of disease
Outcome measures
| Measure |
Experimental Arm
n=15 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
PFS Analysis by PD-L1
Negative PDL-1
|
2.3 Month
Interval 1.2 to 6.2
|
|
PFS Analysis by PD-L1
Positive PDL-1
|
5.7 Month
Interval 4.1 to 17.0
|
SECONDARY outcome
Timeframe: From the inclusion date to the progression or death, due to any cause, up to 24 months. patient who does not progresses neither dies, is censored at the last tumor evaluation where no progression is detected.Population: Kaplan-Meier model- Summary results of PFS by the effect of the presence of Integrase Inhibitors
Defined as the length of time from the date of diagnosis to the date of the first documented progression of disease
Outcome measures
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
PFS Analysis by Integrase Inhibitors
Integrase Inhibitors
|
2.5 Months
Interval 1.4 to 9.6
|
|
PFS Analysis by Integrase Inhibitors
No Integrase Inhibitors
|
2.5 Months
Interval 0.4 to 6.2
|
SECONDARY outcome
Timeframe: From the inclusion date to the progression or death, due to any cause, assessed up to 24 months.Population: Effect of the presence of Dolutegravir, in the PFS in cancer patients
PFS is defined as the time from the inclusion date to the progression or death, due to any cause, date.
Outcome measures
| Measure |
Experimental Arm
n=20 Participants
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
PFS Analysis by Dolutegravir
Dolutegravir
|
4.2 Month
Interval 1.0 to 17.0
|
|
PFS Analysis by Dolutegravir
No Dolutegravir
|
2.3 Month
Interval 0.4 to 4.1
|
Adverse Events
Experimental Arm
Serious events: 11 serious events
Other events: 20 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Experimental Arm
n=20 participants at risk
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Vascular disorders
Vascular arterial ischemia
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Blood and lymphatic system disorders
Creatinine increased
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
General disorders
Death NOS
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
General disorders
Pain
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Hepatobiliary disorders
Hepatic toxicity
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Infections and infestations
Lung infection
|
25.0%
5/20 • Number of events 5 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Infections and infestations
Coronavirus infection
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
Other adverse events
| Measure |
Experimental Arm
n=20 participants at risk
Durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients
Durvalumab: Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled.
|
|---|---|
|
Vascular disorders
Hypotension
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Vascular disorders
Thromboembolic event
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
General disorders
Asthenia
|
70.0%
14/20 • Number of events 14 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
General disorders
Pain
|
60.0%
12/20 • Number of events 12 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
General disorders
Fever
|
30.0%
6/20 • Number of events 6 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Psychiatric disorders
Anxiety
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.0%
7/20 • Number of events 7 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Reproductive system and breast disorders
Prostate syndrom
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Investigations
Serum amylase increased
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Investigations
Creatinine increased
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Cardiac disorders
Arrhythmia
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Cardiac disorders
Percardial effusion
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.0%
7/20 • Number of events 7 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
20.0%
4/20 • Number of events 4 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Nervous system disorders
Ataxia
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • Number of events 7 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Number of events 4 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Dysphagia
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Mucositis oral
|
15.0%
3/20 • Number of events 3 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Hepatobiliary disorders
Hepatic toxicity
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
4/20 • Number of events 4 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Skin and subcutaneous tissue disorders
Seborreic dermatitis
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
10/20 • Number of events 10 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Metabolism and nutrition disorders
Anorexia
|
35.0%
7/20 • Number of events 7 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 1 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Infections and infestations
Lung infection
|
20.0%
4/20 • Number of events 4 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
|
Infections and infestations
Non respiratory infection
|
10.0%
2/20 • Number of events 2 • 24 month
The severity of AE will be determined using CTCAE version 4.0.3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place