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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival. This study will also search for genes involved in the response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temsirolimus | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temsirolimus | Drug | Temsirolimus |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-progression Rate at 2 Months | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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. | Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine HOUEDE, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33076 | France | |||
| Centre François Baclesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29454321 | Result | Pulido M, Roubaud G, Cazeau AL, Mahammedi H, Vedrine L, Joly F, Mourey L, Pfister C, Goberna A, Lortal B, Bellera C, Pourquier P, Houede N. Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer. BMC Cancer. 2018 Feb 17;18(1):194. doi: 10.1186/s12885-018-4059-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Non-progression Rate at 2 Months | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Blood/Bone Marrow (SOC from CTCAE v3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Blood/Bone Marrow (SOC from CTCAE v3.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nadine Houede, oncologist | Institut Bergonie | 05.56.33.33.33 | nadine.HOUEDE@chu-nimes.fr |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
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| Progression-free Survival | 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. | Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months) |
| Caen |
| 14076 |
| France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| CHU Henri Mondor | Créteil | 94010 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Hôpital d'instruction des armées du Val-de-Grâce | Paris | 75230 | France |
| CHU de Rouen | Rouen | 76031 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Survival | 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. | Posted | Median | 95% Confidence Interval | months | Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months) |
|
|
|
| Secondary | Progression-free Survival | 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. | Posted | Median | 95% Confidence Interval | months | Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months) |
|
|
|
| 40 |
| 53 |
| 35 |
| 53 |
| 53 |
| 53 |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment | Blood/Bone Marrow (SOC from CTCAE v3.0) |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Constitutional Symptoms - Other (Specify, __) | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Obstruction, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL (SOC from CTCAE v3.0) |
|
| Hemorrhage, CNS | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | HEMORRHAGE/BLEEDING (SOC from CTCAE v3.0) |
|
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | HEPATOBILIARY / PANCREAS (SOC from CTCAE v3.0) |
|
| Infection - Other (Specify, __) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | INFECTION (SOC from CTCAE v3.0) |
|
| Infection with unknown ANC | Infections and infestations | CTCAE (3.0) | Systematic Assessment | INFECTION (SOC from CTCAE v3.0) |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC LABORATORY (SOC from CTCAE v3.0) |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0) |
|
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0) |
|
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY (SOC from CTCAE v3.0) |
|
| Mood alteration | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY (SOC from CTCAE v3.0) |
|
| Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | PAIN (SOC from CTCAE v3.0) |
|
| Pain - Other (Specify, __) | General disorders | CTCAE (3.0) | Systematic Assessment | PAIN (SOC from CTCAE v3.0) |
|
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY / UPPER RESPIRATORY (SOC from CTCAE v3.0) |
|
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY / UPPER RESPIRATORY (SOC from CTCAE v3.0) |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE v3.0) |
|
| Renal/Genitourinary - Other (Specify, __) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE v3.0) |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE v3.0) |
|
|
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment | Blood/Bone Marrow (SOC from CTCAE v3.0) |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment | Blood/Bone Marrow (SOC from CTCAE v3.0) |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment | CARDIAC GENERAL (SOC from CTCAE V3.0) |
|
| Constitutional Symptoms - Other (Specify, __) | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0) |
|
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE V3.0) |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE V3.0) |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE V3.0) |
|
| Rash/desquamation | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | DERMATOLOGY/SKIN (SOC from CTCAE V3.0) |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Gastrointestinal - Other (Specify, __) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Obstruction, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastrointestinal (SOC from CTCAE V3.0) |
|
| Hemorrhage, GU | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | HEMORRHAGE/BLEEDING (SC from CTCAE V3.0) |
|
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | HEMORRHAGE/BLEEDING (SC from CTCAE V3.0) |
|
| Infection - Other (Specify, __) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | INFECTION (SOC from CTCAE V3.0) |
|
| Edema:limb | General disorders | CTCAE (3.0) | Systematic Assessment | LYMPHATICS (SOC from CTCAE V3.0) |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Cholesterol, serum-high (hypercholesteremia) | Investigations | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Metabolic/Laboratory - Other (Specify, __) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | METABOLIC/LABORATORY (SOC from CTCAE V3.0) |
|
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE V3.0) |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY (SOC from CTCAE V3.0) |
|
| Mood alteration | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY (SOC from CTCAE V3.0) |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY (SOC from CTCAE V3.0) |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment | PAIN (SOC from CTCAEV3.0) |
|
| Pain - Other (Specify, __) | General disorders | CTCAE (3.0) | Systematic Assessment | PAIN (SOC from CTCAEV3.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY/UPPER RESPIRATORY (SOC from CTCAE V3.0) |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY/UPPER RESPIRATORY (SOC from CTCAE V3.0) |
|
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY/UPPER RESPIRATORY (SOC from CTCAE V3.0) |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE V3.0) |
|
| Renal/Genitourinary - Other (Specify, __) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY (SOC from CTCAE V3.0) |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |