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| ID | Type | Description | Link |
|---|---|---|---|
| ETUDE RESUME | Other Identifier | Alias Study Number |
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Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Interventional Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib: observational study | Other | Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival With Sunitinib as First Line of Therapy | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. | From start of treatment up to 66.6 months |
| Progression Free Survival for Re-challenge With Sunitinib | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. | From start of treatment up to 52.2 months |
| Progression Free Survival: Second Line of Treatment | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus). | From start of treatment up to 22.9 months |
| Progression Free Survival: Third Line Treatment | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12. | Baseline up to death or end of study (up to 98.0 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Inclusion Criteria:
Exclusion Criteria:
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mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de la Timone | Marseille | Cedex 5 | 13335 | France | ||
| Hopital albert Michalon |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Evaluable population: All participants included in the analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Progression Free Survival With Sunitinib as First Line of Therapy | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. | Evaluable population: All participants included in the analysis. | Posted | Median | 95% Confidence Interval | months | From start of treatment up to 66.6 months |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metastatic Renal Cell Carcinoma (mRCC) Cohort | Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| From start of treatment up to 23.7 months |
| Percentage of Participants With Objective Response | Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more. | Baseline up to 98.0 months |
| Baseline up to 24 months |
| Grenoble |
| Cedex 9 |
| 38043 |
| France |
| Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire | Saint-Priest-en-Jarez | France | 42271 | France |
| Centre Paul Papin | Angers | 49100 | France |
| Hôpital Saint-André | Bordeaux | 33075 | France |
| Centre Catalan Urologie Andrologie | Cabestany | 66330 | France |
| Centre Oscar Lambret - Cancérologie Urologie Digestive | Lille | 59020 | France |
| clinique de la Louvière | Lille | 59042 | France |
| Hopital Dupuytren - Oncologie Medicale | Limoges | 87042 | France |
| Centre Leon Berard, Service d'Oncologie Medicale | Lyon | 69373 | France |
| Institut Paoli-Calmettes / Hôpital de jour | Marseille | 13273 Cedex 9 | France |
| Hopital Timone Adultes | Marseille | 13385 | France |
| Hopital Europeen Georges Pompidou | Paris | 75908 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| CHU Charles Nicolle | Rouen | 76031 | France |
| Centre Rene Gauducheau - Service Oncologie Medicale | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31000 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Discontinued prior initiation: sunitinib |
|
| Did not complete re-challenge |
|
| Disease progression |
|
| Intolerance to treatment |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Survival | Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12. | Evaluable population: All participants included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to death or end of study (up to 98.0 months) |
|
|
|
| Secondary | Percentage of Participants With Objective Response | Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more. | Evaluable population: All participants included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 98.0 months |
|
|
|
| Other Pre-specified | Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Evaluable population: All participants included in the analysis. | Posted | Number | participants | Baseline up to 24 months |
|
|
|
| Primary | Progression Free Survival for Re-challenge With Sunitinib | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. | Evaluable population: All participants included in the analysis. Here "N" signifies number of participants who were analyzed for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From start of treatment up to 52.2 months |
|
|
|
| Primary | Progression Free Survival: Second Line of Treatment | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus). | Evaluable population: All participants included in the analysis. Here "N" signifies number of participants who were analyzed for this outcome measure and "n" signifies those participants who were evaluable for respective treatment group. | Posted | Median | 95% Confidence Interval | months | From start of treatment up to 22.9 months |
|
|
|
| Primary | Progression Free Survival: Third Line Treatment | The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus). | Evaluable population: All participants included in the analysis. Here "N" signifies number of participants who were analyzed for this outcome measure and "n" signifies those participants who were evaluable for respective treatment group. | Posted | Median | 95% Confidence Interval | months | From start of treatment up to 23.7 months |
|
|
|
| 21 |
| 52 |
| 13 |
| 52 |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Clavicle fracture | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
|
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|