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See Detailed Description for Termination Reason
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To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.
The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | sunitinib + exemestane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exemestane | Drug | 25 mg, oral, daily dosing |
| |
| sunitinib malate |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7. | From start of treatment until Day 1 of every other cycle (8 weeks) or death |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Atlanta | Georgia | 30322 | United States | ||
| Pfizer Investigational Site |
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 | Sunitinib + Exemestane | Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
37.5 mg, oral, continuous dosing, daily |
|
|
| From start of treatment until Day 1 of every other cycle (8 weeks) |
| Duration of Response (DR) | DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7. | From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer |
| Overall Survival (OS) | OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7. | From start of study treatment until death |
| Time to Tumor Progression (TTP) | TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7. | From start of treatment until Day 1 of every other cycle (8 weeks) |
| Clinical Benefit Rate (CBR) | The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response. | From start of treatment until Day 1 of every other cycle (8 weeks) |
| Montreal |
| Quebec |
| H3G 1A4 |
| Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3G 1L5 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib + Exemestane | Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 (PFS) | PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7. | Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination. | Posted | Mean | Standard Deviation | weeks | From start of treatment until Day 1 of every other cycle (8 weeks) or death |
|
| ||||||||||||||||
| Secondary | Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) | OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start. | Analyses on OR were performed for subjects who received at least 1 dose of study medication. | Posted | Number | participants | From start of treatment until Day 1 of every other cycle (8 weeks) |
|
| |||||||||||||||||
| Secondary | Duration of Response (DR) | DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7. | Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination. | Posted | Mean | Standard Deviation | weeks | From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer |
|
| ||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7. | ITT. Data were not analyzed due to early termination. | Posted | Mean | Standard Deviation | weeks | From start of study treatment until death |
|
| ||||||||||||||||
| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7. | ITT. Data were not analyzed due to early termination. | Posted | Mean | Standard Deviation | weeks | From start of treatment until Day 1 of every other cycle (8 weeks) |
|
| ||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response. | ITT. Data were not analyzed due to early termination. | Posted | Number | rate | From start of treatment until Day 1 of every other cycle (8 weeks) |
|
|
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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 | Sunitinib + Exemestane | Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily. | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myodesopsia | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fibrosis | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Induration | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vaginal disorder | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Title | Measurements |
|---|---|
|
| > = 65 years |
|
|