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The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1208 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1208 | Drug | Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period. | Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Neumann, MSD | AZ | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chūōku | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR\_Synopsis\_D4510C00005.pdf | View source |
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43 patients were enrolled to the study, of which 35 recieved doses of AZD1208 between 120mg and 800mg. The other 8 patients did not receive AZD1208.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD1208 120mg | Once daily continuous dosing schedule. |
| FG001 | AZD1208 240mg | Once daily continuous dosing schedule. |
| FG002 | AZD1208 360mg | Once daily continuous dosing schedule. |
| FG003 | AZD1208 540mg | Once daily continuous dosing schedule. |
| FG004 | AZD1208 700mg | Once daily continuous dosing schedule. |
| FG005 | AZD1208 800mg | Once daily continuous dosing schedule. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1208 120mg | Once daily continuous dosing schedule. |
| BG001 | AZD1208 240mg | Once daily continuous dosing schedule. |
| 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 | Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period. | All patients who were evaluable for Response analysis set for RECIST criteria | Posted | Number | Participants | Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1 |
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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 | AZD1208 120mg | Once daily continuous dosing schedule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial Infection | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Keating | AstraZeneca | +1 781 839 4182 | karen.keating@astrazeneca.com |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C587575 | AZD1208 |
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| Manchester |
| United Kingdom |
| Research Site | Surrey | United Kingdom |
| Adverse Event |
|
| Condition Under Investigation Worsened |
|
| BG002 | AZD1208 360mg | Once daily continuous dosing schedule. |
| BG003 | AZD1208 540mg | Once daily continuous dosing schedule. |
| BG004 | AZD1208 700mg | Once daily continuous dosing schedule. |
| BG005 | AZD1208 800mg | Once daily continuous dosing schedule. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | AZD1208 240mg | Once daily continuous dosing schedule. | 2 | 7 | 7 | 7 |
| EG002 | AZD1208 360mg | Once daily continuous dosing schedule. | 2 | 6 | 6 | 6 |
| EG003 | AZD1208 540mg | Once daily continuous dosing schedule. | 2 | 7 | 7 | 7 |
| EG004 | AZD1208 700mg | Once daily continuous dosing schedule. | 2 | 6 | 6 | 6 |
| EG005 | AZD1208 800mg | Once daily continuous dosing schedule. | 0 | 6 | 6 | 6 |
| Balance Disorder | Nervous system disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Intestinal Obstruction | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Pollakiuria | Renal and urinary disorders |
|
| Fatigue | General disorders |
|
| General Physical Health Deterioration | General disorders |
|
| Oral Candidiasis | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Bacterial Infection | Infections and infestations |
|
| Lower Respiratory Tract Infection | Infections and infestations |
|
| Lung Infection | Infections and infestations |
|
| Paronychia | Infections and infestations |
|
| Vaginal Infection | Infections and infestations |
|
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Anaemia | Blood and lymphatic system disorders |
|
| Thrombocytopenia | Blood and lymphatic system disorders |
|
| Leukopenia | Blood and lymphatic system disorders |
|
| Lymphadenitis | Blood and lymphatic system disorders |
|
| Decreased Appetite | Metabolism and nutrition disorders |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders |
|
| Hyperglycaemia | Metabolism and nutrition disorders |
|
| Hyponatraemia | Metabolism and nutrition disorders |
|
| Hypokalaemia | Metabolism and nutrition disorders |
|
| Hypophosphataemia | Metabolism and nutrition disorders |
|
| Hypocalcaemia | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Hypomagnesaemia | Metabolism and nutrition disorders |
|
| Polydipsia | Metabolism and nutrition disorders |
|
| Insomnia | Psychiatric disorders |
|
| Anxiety | Psychiatric disorders |
|
| Lethargy | Nervous system disorders |
|
| Dysgeusia | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
|
| Ataxia | Nervous system disorders |
|
| Balance Disorder | Nervous system disorders |
|
| Disturbance In Attention | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Dysaesthesia | Nervous system disorders |
|
| Neuropathy Peripheral | Nervous system disorders |
|
| Sensory Disturbance | Nervous system disorders |
|
| Dry Eye | Eye disorders |
|
| Vision Blurred | Eye disorders |
|
| Atrial Fibrillation | Cardiac disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
|
| Dysaesthesia Pharynx | Respiratory, thoracic and mediastinal disorders |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders |
|
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders |
|
| Hepatic Pain | Hepatobiliary disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Abdominal Discomfort | Gastrointestinal disorders |
|
| Abdominal Distension | Gastrointestinal disorders |
|
| Abdominal Tenderness | Gastrointestinal disorders |
|
| Cheilitis | Gastrointestinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders |
|
| Haemorrhoids | Gastrointestinal disorders |
|
| Intestinal Obstruction | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Dry Skin | Skin and subcutaneous tissue disorders |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders |
|
| Rash Macular | Skin and subcutaneous tissue disorders |
|
| Nail Disorder | Skin and subcutaneous tissue disorders |
|
| Psoriasis | Skin and subcutaneous tissue disorders |
|
| Purpura | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Skin Exfoliation | Skin and subcutaneous tissue disorders |
|
| Skin Fissures | Skin and subcutaneous tissue disorders |
|
| Skin Mass | Skin and subcutaneous tissue disorders |
|
| Urticaria | Skin and subcutaneous tissue disorders |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Flank Pain | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders |
|
| Neck Pain | Musculoskeletal and connective tissue disorders |
|
| Proteinuria | Renal and urinary disorders |
|
| Dysuria | Renal and urinary disorders |
|
| Cystitis Noninfective | Renal and urinary disorders |
|
| Haematuria | Renal and urinary disorders |
|
| Hydronephrosis | Renal and urinary disorders |
|
| Pollakiuria | Renal and urinary disorders |
|
| Polyuria | Renal and urinary disorders |
|
| Urinary Incontinence | Renal and urinary disorders |
|
| Pelvic Pain | Reproductive system and breast disorders |
|
| Vulvovaginal Pruritus | Reproductive system and breast disorders |
|
| Fatigue | General disorders |
|
| Pyrexia | General disorders |
|
| Chest Pain | General disorders |
|
| Chills | General disorders |
|
| Device Occlusion | General disorders |
|
| General Physical Health Deterioration | General disorders |
|
| Hernia | General disorders |
|
| Malaise | General disorders |
|
| Mucosal Inflammation | General disorders |
|
| Oedema Peripheral | General disorders |
|
| Suprapubic Pain | General disorders |
|
| Platelet Count Decreased | Investigations |
|
| White Blood Cell Count Decreased | Investigations |
|
| Gamma-Glutamyltransferase Increased | Investigations |
|
| Aspartate Aminotransferase Increased | Investigations |
|
| Blood Creatinine Increased | Investigations |
|
| Lymphocyte Count Decreased | Investigations |
|
| Alanine Aminotransferase Increased | Investigations |
|
| Blood Alkaline Phosphatase Increased | Investigations |
|
| Neutrophil Count Decreased | Investigations |
|
| Oxygen Saturation Decreased | Investigations |
|
| Blood Creatine Phosphokinase Increased | Investigations |
|
| Blood Urea Increased | Investigations |
|
| Breath Sounds Abnormal | Investigations |
|
| Electrocardiogram Qt Prolonged | Investigations |
|
| Gastrointestinal Stoma Output Decreased | Investigations |
|
| Weight Decreased | Investigations |
|
| Arthropod Bite | Injury, poisoning and procedural complications |
|
| Fall | Injury, poisoning and procedural complications |
|
AstraZeneca will manage the publication of the results of the Clinical Trial in partnership with the authors. AstraZeneca recognises that Institutions/Investigators may wish to make publications regarding Clinical Trial results. The Institution/Investigator agrees to collaborate in good faith with AstraZeneca. Prior to any such publication, the Institution/Investigator shall provide AstraZeneca with preliminary data and drafts of proposed publications.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |