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The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZD4054 10 mg | Experimental | 1 x 10 mg oral tablets once daily |
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| ZD4054 15 mg | Experimental | 1 x 10 mg + 2 x 2.5 mg oral tablets once daily |
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| ZD4054 22.5 mg | Experimental | 2 x 10 mg + 1 x 2.5 mg oral tablets once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD4054 10 mg | Drug | 1 x 10 mg oral tablets once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLTs) | DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported. | Baseline to Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Prostate Specific Antigen (PSA) Concentration | Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). | Baseline to Day 15. |
| Change in Total Prostate Specific Antigen (PSA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cleveland | Ohio | 44195 | United States | ||
| Research Site |
6 of the 22 screened patients were not entered into the study as they did not fulfill the study eligibility criteria.
22 male patients with metastatic prostate cancer and rising Prostate Specific Antigen (PSA) levels were recruited from 11th June 2003 (last subject completed on 31st October 2005). This study was conducted in 2 centres in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZD4054 10 mg | ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily |
| FG001 | ZD4054 15 mg | ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Dose Escalation Period |
|
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| ZD4054 15 mg | Drug | 1 x 10 mg + 2 x 2.5 mg oral tablets once daily |
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| ZD4054 22.5 mg | Drug | 2 x 10 mg + 2 x 2.5 mg oral tablets once daily |
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Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 |
| Baseline to Day 15. |
| Change in Serum Concentration of Bone Alkaline Phosphatase (ALP) | Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | Baseline to Day 15. |
| Change in Serum Concentration of Procollagen Type I N Propeptide (PINP) | Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | Baseline to Day 15. |
| Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx) | Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | Baseline to Day 15. |
| Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) | Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | Baseline to Day 15. |
| Madison |
| Wisconsin |
| United States |
| FG002 | ZD4054 22.5 mg | ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2: Extension Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | ZD4054 10 mg | ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily |
| BG001 | ZD4054 15 mg | ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily |
| BG002 | ZD4054 22.5 mg | ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Height | Mean | Standard Deviation | Centimeters (cm) |
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| Weight | Mean | Standard Deviation | Kilograms (kg) |
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| 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 | Dose Limiting Toxicities (DLTs) | DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported. | Posted | Number | Participants | Baseline to Day 29. |
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| Secondary | Total Prostate Specific Antigen (PSA) Concentration | Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). | All dosed patients. | Posted | Geometric Mean | Full Range | ng/ml | Baseline to Day 15. |
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| Secondary | Change in Total Prostate Specific Antigen (PSA) | Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | The analysis population includes only patients dosed with ZD4054 | Posted | Mean | Standard Deviation | Percentage Change | Baseline to Day 15. |
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| Secondary | Change in Serum Concentration of Bone Alkaline Phosphatase (ALP) | Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | The analysis population includes only patients dosed with ZD4054 | Posted | Mean | Standard Deviation | Percentage Change | Baseline to Day 15. |
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| Secondary | Change in Serum Concentration of Procollagen Type I N Propeptide (PINP) | Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | The analysis population includes only patients dosed with ZD4054 | Posted | Mean | Standard Deviation | Percentage Change | Baseline to Day 15. |
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| Secondary | Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx) | Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | The analysis population includes only patients dosed with ZD4054 | Posted | Mean | Standard Deviation | Percentage Change | Baseline to Day 15. |
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| Secondary | Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) | Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2). Percentage change = [(measure at Day 15 - measure at baseline)/measure at baseline]*100 | The analysis population includes only patients dosed with ZD4054 | Posted | Mean | Standard Deviation | Percentage Change | Baseline to Day 15. |
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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 | ZD4054 10 mg | ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily | 0 | 3 | 3 | 3 | ||
| EG001 | ZD4054 15 mg | ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily | 2 | 10 | 10 | 10 | ||
| EG002 | ZD4054 22.5 mg | ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Intraventricular Haemorrhage | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Pitting Oedema | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
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| Ear Discomfort | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 9.0 | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA 9.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 9.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Tongue Discolouration | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Face Oedema | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Animal Bite | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Barotrauma | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Joint Sprain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Weight Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Weight Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Electrocardiogram Qt Corrected Interval Prolonged | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Haemoglobin Decreased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Heart Rate Increased | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Buttock Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Burning Sensation | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Neuropathy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Testicular Pain | Reproductive system and breast disorders | MedDRA 9.0 | Systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Periorbital Oedema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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One patient received one dose of 22.5 mg and was dose reduced to 15 mg thereafter. This patient was classified into the 15 mg dose group, except for the single dose pharmacokinetic results (not posted).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C511404 | ZD4054 |
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| Male |
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| Black |
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| Oriental |
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| Other |
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