Trial Outcomes & Findings for Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer (NCT NCT01827943)
NCT ID: NCT01827943
Last Updated: 2021-05-06
Results Overview
Non-progression rate is defined as the rate of participants in complete or partial response or stable disease according to RECIST V1.1. Complete response is defined as the disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease occurs when neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
2 months
Results posted on
2021-05-06
Participant Flow
Participant milestones
| Measure |
Temsirolimus
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
Safety Population
|
53
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Temsirolimus
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Never treated because of an rapid progression
|
1
|
Baseline Characteristics
Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Baseline characteristics by cohort
| Measure |
Temsirolimus
n=54 Participants
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Age, Continuous
|
65.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsNon-progression rate is defined as the rate of participants in complete or partial response or stable disease according to RECIST V1.1. Complete response is defined as the disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease occurs when neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Temsirolimus
n=45 Participants
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Non-progression Rate at 2 Months
|
48.9 percentage of participants
Interval 33.7 to 64.2
|
SECONDARY outcome
Timeframe: Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)OS was was defined as the time from the treatment initiation to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Temsirolimus
n=45 Participants
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Overall Survival
|
7.2 months
Interval 5.2 to 9.5
|
SECONDARY outcome
Timeframe: Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months)Progression-free survival (PFS) was defined as the time from the initiation of treatment to the first documented progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Patients alive and progression free were censored at the date of last follow-up or last patient contact. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Temsirolimus
n=45 Participants
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Progression-free Survival
|
2.8 months
Interval 1.8 to 3.7
|
Adverse Events
Temsirolimus
Serious events: 35 serious events
Other events: 53 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Temsirolimus
n=53 participants at risk
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.7%
3/53 • Number of events 3
|
|
Investigations
Platelets
|
5.7%
3/53 • Number of events 3
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
11.3%
6/53 • Number of events 7
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
24.5%
13/53 • Number of events 15
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
1.9%
1/53 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
3.8%
2/53 • Number of events 2
|
|
Gastrointestinal disorders
Obstruction, GI
|
7.5%
4/53 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Number of events 1
|
|
Nervous system disorders
Hemorrhage, CNS
|
3.8%
2/53 • Number of events 2
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
1.9%
1/53 • Number of events 1
|
|
Infections and infestations
Infection - Other (Specify, __)
|
17.0%
9/53 • Number of events 10
|
|
Infections and infestations
Infection with unknown ANC
|
1.9%
1/53 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
1.9%
1/53 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/53 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
1.9%
1/53 • Number of events 1
|
|
Psychiatric disorders
Mood alteration
|
1.9%
1/53 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.9%
1/53 • Number of events 1
|
|
General disorders
Pain - Other (Specify, __)
|
9.4%
5/53 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
1.9%
1/53 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
5.7%
3/53 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
3.8%
2/53 • Number of events 2
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
3.8%
2/53 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
1.9%
1/53 • Number of events 1
|
Other adverse events
| Measure |
Temsirolimus
n=53 participants at risk
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Temsirolimus: Temsirolimus
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
49.1%
26/53 • Number of events 40
|
|
Investigations
Leukocytes (total WBC)
|
5.7%
3/53 • Number of events 4
|
|
Investigations
Platelets
|
30.2%
16/53 • Number of events 24
|
|
Vascular disorders
Hypertension
|
7.5%
4/53 • Number of events 4
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
37.7%
20/53 • Number of events 21
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
73.6%
39/53 • Number of events 43
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
39.6%
21/53 • Number of events 26
|
|
Psychiatric disorders
Insomnia
|
9.4%
5/53 • Number of events 5
|
|
Investigations
Weight loss
|
20.8%
11/53 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
24.5%
13/53 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
26.4%
14/53 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.1%
8/53 • Number of events 11
|
|
Injury, poisoning and procedural complications
Rash/desquamation
|
15.1%
8/53 • Number of events 10
|
|
Metabolism and nutrition disorders
Anorexia
|
43.4%
23/53 • Number of events 26
|
|
Gastrointestinal disorders
Constipation
|
24.5%
13/53 • Number of events 13
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
28.3%
15/53 • Number of events 20
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
5.7%
3/53 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.7%
3/53 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
35.8%
19/53 • Number of events 23
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
5.7%
3/53 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
43.4%
23/53 • Number of events 24
|
|
Gastrointestinal disorders
Obstruction, GI
|
11.3%
6/53 • Number of events 7
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
18.9%
10/53 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
28.3%
15/53 • Number of events 19
|
|
Renal and urinary disorders
Hemorrhage, GU
|
5.7%
3/53 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
11.3%
6/53 • Number of events 6
|
|
Infections and infestations
Infection - Other (Specify, __)
|
58.5%
31/53 • Number of events 45
|
|
General disorders
Edema:limb
|
26.4%
14/53 • Number of events 14
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
5.7%
3/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
7.5%
4/53 • Number of events 4
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
13.2%
7/53 • Number of events 7
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
11.3%
6/53 • Number of events 6
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __)
|
5.7%
3/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.7%
3/53 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
7.5%
4/53 • Number of events 6
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
24.5%
13/53 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
11.3%
6/53 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
5.7%
3/53 • Number of events 3
|
|
Psychiatric disorders
Mood alteration
|
24.5%
13/53 • Number of events 15
|
|
Nervous system disorders
Neuropathy: sensory
|
11.3%
6/53 • Number of events 8
|
|
General disorders
Pain
|
54.7%
29/53 • Number of events 61
|
|
General disorders
Pain - Other (Specify, __)
|
9.4%
5/53 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
6/53 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.3%
6/53 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
7.5%
4/53 • Number of events 4
|
|
Renal and urinary disorders
Renal failure
|
17.0%
9/53 • Number of events 10
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
7.5%
4/53 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place