Last reviewed · How we verify
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
Phase 1 trial testing AZD4547 in Cancer in 95 participants. Terminated before completion.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 95 |
| Start date | 21 October 2009 |
| Primary completion | 12 February 2014 |
| Estimated completion | 5 March 2015 |
| Sites | 29 locations across France, Italy, Netherlands, United Kingdom, Germany, United States, Spain |
AstraZeneca — full company profile →
Adults 25 to 149, any sex, with Cancer or Advanced Solid Malignancies. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 1818 | ± 59.43 |
| Part A | 2697 | ± 110.8 |
To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is \>=30% reduction in sum of longest diameter of target lesions
| Group | Value | 95% CI |
|---|---|---|
| Part B | 0 | |
| Part C (FISH Ratio >= 2) | 1 | |
| Part A | 0 | |
| Part C (FISH Ratio < 2) | 0 |
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 112.0 | ± 81.47 |
| Part A | 167.4 | ± 112.1 |
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 289.3 | ± 45.98 |
| Part A | 297.1 | ± 123.5 |
To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 2606 | ± 41.32 |
| Part A | 2337 | ± 125.2 |
To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 6 | |
| Part C (FISH Ratio >= 2) | 33 | |
| Part C (FISH Ratio <2) | 12 | |
| Part A | 43 |
To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 6 | |
| Part C (FISH Ratio >= 2) | 31 | |
| Part C (FISH Ratio <2) | 10 | |
| Part A | 42 |
To investigate the safety and tolerability of AZD4547
| Group | Value | 95% CI |
|---|---|---|
| Part B | 1 | |
| Part C (FISH Ratio >= 2) | 16 | |
| Part C (FISH Ratio <2) | 5 | |
| Part A | 17 |
To investigate the safety and tolerability of AZD4547
| Group | Value | 95% CI |
|---|---|---|
| Part B | 0 | |
| Part C (FISH Ratio >= 2) | 8 | |
| Part C (FISH Ratio <2) | 3 | |
| Part A | 12 |
To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.
| Group | Value | 95% CI |
|---|---|---|
| Part B | 1 | |
| Part C (FISH Ratio >= 2) | 10 | |
| Part C (FISH Ratio <2) | 3 | |
| Part A | 11 |
To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547
| Group | Value | 95% CI |
|---|---|---|
| Part B | 1 | |
| Part C (FISH Ratio >= 2) | 5 | |
| Part C (FISH Ratio <2) | 0 | |
| Part A | 5 |
Time frame: AEs were collected on a continual basis from Screening up until the end of the 28 day follow up period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part B | Part C (FISH Ratio >= 2) | Part C (FISH Ratio < 2) | Part A |
|---|---|---|---|---|---|
| Renal failure | Renal and urinary disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — |
| Chorioretinopathy | Eye disorders | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| ALT increased | Investigations | — | — | — | — |
| GGT increased | Investigations | — | — | — | — |
| Hydronephrosis | Renal and urinary disorders | — | — | — | — |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — | — | — |
| Pelvi-ureteric obstruction | Renal and urinary disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Retinal detachment | Eye disorders | — | — | — | — |
| Tumour associated fever | General disorders | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Atrial flutter | Vascular disorders | — | — | — | — |
| Bile duct obstruction | Hepatobiliary disorders | — | — | — | — |
| Decreased appetite | Gastrointestinal disorders | — | — | — | — |
| Delirium | Psychiatric disorders | — | — | — | — |
| Epilepsy | Nervous system disorders | — | — | — | — |
| Euthanasia | Social circumstances | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypotension | Nervous system disorders | — | — | — | — |
| Reaction | System | Part B | Part C (FISH Ratio >= 2) | Part C (FISH Ratio < 2) | Part A |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hyperphosphataemia | Metabolism and nutrition disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Stomatis | Gastrointestinal disorders | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — |
| Nail disorder | Skin and subcutaneous tissue disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Ageusia | Metabolism and nutrition disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Lethargy | Nervous system disorders | — | — | — | — |
| Oedema peripheral | Eye disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — |
| Dyspepsia | Nervous system disorders | — | — | — | — |
| Muscle spasms | Nervous system disorders | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Breath sounds abnormal | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Insomnia | Nervous system disorders | — | — | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| ALT increased | Investigations | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
Most-reported serious reactions: Renal failure, Dyspnoea, General physical health deterioration, Chorioretinopathy, Dehydration, Anaemia, ALT increased, GGT increased.
Data from ClinicalTrials.gov NCT00979134 adverse events section.
This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00979134.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing