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Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
Phase 1 trial testing AZD9291 tablets in Advanced Non Small Cell Lung Cancer in 38 participants. Completed in 24 January 2023.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Masking | none |
| Primary purpose | other |
| Enrollment | 38 |
| Start date | 14 November 2014 |
| Primary completion | 24 March 2015 |
| Estimated completion | 24 January 2023 |
| Sites | 13 locations across France, United Kingdom, Spain, South Korea |
AstraZeneca — full company profile →
Adults 18 to 99, any sex, with Advanced Non Small Cell Lung Cancer or Advanced (Inoperable) Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 7403 | 3170 – 15600 |
| Fasted | 7345 | 3400 – 14700 |
Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 199.6 | 80.8 – 446 |
| Fasted | 218.0 | 95.2 – 381 |
Area under the plasma concentration curve from zero extrapolated to infinity.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 11640 | 5460 – 24100 |
| Fasted | 12530 | 6050 – 25500 |
Area under the plasma concentration curve from time zero to last quantifiable dose.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 10820 | 4860 – 21800 |
| Fasted | 10630 | 5300 – 22600 |
Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 9549 | 4360 – 18800 |
| Fasted | 9308 | 4480 – 18900 |
Pharmacokinetics of AZD9291 by assessment of time to Cmax.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 7.97 | 3.02 – 24.13 |
| Fasted | 6.08 | 3.00 – 10.07 |
Pharmacokinetics of AZD9291 by assessment of the terminal half-life.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 52.82 | 32.1 – 84.4 |
| Fasted | 54.64 | 31.2 – 84.0 |
Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 13.75 | 6.65 – 29.3 |
| Fasted | 12.78 | 6.28 – 26.5 |
Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 1024 | 470 – 2580 |
| Fasted | 1019 | 432 – 2200 |
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 497.6 | 138 – 1360 |
| Fasted | 613.2 | 270 – 1450 |
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 235.0 | 82.7 – 1140 |
| Fasted | 266.4 | 112 – 590 |
Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 9.163 | 2.94 – 24.7 |
| Fasted | 11.95 | 4.95 – 28.6 |
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 4.236 | 1.76 – 19.7 |
| Fasted | 5.109 | 1.78 – 11.3 |
Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 1033 | 266 – 2590 |
| Fasted | 1132 | 535 – 2640 |
| Group | Value | 95% CI |
|---|---|---|
| Fed (High-fat Meal) | 584.5 | 178 – 2530 |
| Fasted | 591.9 | 270 – 1090 |
Time frame: Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 months for Overall (Parts A and B combined).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Overall Safety Population | Part A Safety Population | Part B Safety Population |
|---|---|---|---|---|
| PNEUMONIA | Infections and infestations | — | — | — |
| ATRIAL FLUTTER | Cardiac disorders | — | — | — |
| LOWER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | — | — | — |
| NEUTROPENIC SEPSIS | Infections and infestations | — | — | — |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | — | — | — |
| SEPSIS | Infections and infestations | — | — | — |
| HYPONATRAEMIA | Metabolism and nutrition disorders | — | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — | — |
| INTERVERTEBRAL DISC COMPRESSION | Musculoskeletal and connective tissue disorders | — | — | — |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Reaction | System | Overall Safety Population | Part A Safety Population | Part B Safety Population |
|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | — | — | — |
| DRY SKIN | Skin and subcutaneous tissue disorders | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — |
| PARONYCHIA | Infections and infestations | — | — | — |
| DECREASED APPETITE | Metabolism and nutrition disorders | — | — | — |
| FATIGUE | General disorders | — | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — | — |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | — | — | — |
| DRY EYE | Eye disorders | — | — | — |
| STOMATITIS | Gastrointestinal disorders | — | — | — |
| ASTHENIA | General disorders | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — |
| RASH MACULAR | Skin and subcutaneous tissue disorders | — | — | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — | — |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — | — | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — | — | — |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | — | — | — |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | — | — | — |
| INSOMNIA | Psychiatric disorders | — | — | — |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | — | — | — |
| CATARACT | Eye disorders | — | — | — |
| LACRIMATION INCREASED | Eye disorders | — | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — | — |
| GASTRITIS | Gastrointestinal disorders | — | — | — |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — | — | — |
| CONJUNCTIVITIS | Infections and infestations | — | — | — |
| HYPOKALAEMIA | Metabolism and nutrition disorders | — | — | — |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | — | — | — |
| NAIL RIDGING | Skin and subcutaneous tissue disorders | — | — | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — | — | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — | — | — |
Most-reported serious reactions: PNEUMONIA, ATRIAL FLUTTER, LOWER RESPIRATORY TRACT INFECTION BACTERIAL, NEUTROPENIC SEPSIS, PNEUMONIA PNEUMOCOCCAL, SEPSIS, HYPONATRAEMIA, BACK PAIN.
Data from ClinicalTrials.gov NCT02163733 adverse events section.
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection. Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal \[fed\], and once in the fasted state \[fasted\]), with a washout period of 9 days between doses. Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 \[TP 2\] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing