- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923947
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
Open-label,Non-randomised,Multicentre,Phase I Study to Assess the Pharmacokinetics, Safety & Tolerability of Osimertinib Following a Single Oral 80mg Dose to Patients w/ Adv Solid Tumours & Normal Renal Function or Severe Renal Impairment.
Study Overview
Detailed Description
This is a 3-part study (Part A, Part B and continued access) in patients with advanced solid tumours (excluding lymphoma) that are refractory to standard therapies or for which no standard therapies exist.
Part A will have a non-randomised, open-label, parallel group, multi-centre design to investigate the pharmacokinetics (PK) of a single dose of osimertinib in patients with severe renal impairment compared with patients with normal renal function. Patients with severe renal impairment will be recruited before those with normal renal function to allow the cohorts to be matched as closely as possible in terms of demographic characteristics (ie, age, body mass index [BMI] and sex).
Approximately 16 patients (8 with severe renal impairment and 8 with normal renal function) are planned to be enrolled to obtain at least 12 evaluable patients (6 with severe renal impairment and 6 with normal renal function) in Part A. A patient with severe renal impairment (as measured by the Cockcroft-Gault equation) is defined as having a creatinine clearance (CrCl) of <30 mL/min whilst a patient with normal renal function has a CrCl of ≥90 mL/min. Both the severe renal impairment and normal renal function patients will be recruited such that both groups will be matched for age, sex, and BMI to the maximum extent possible.
In Part A, each patient will receive a single oral dose of osimertinib 80 mg (given as a tablet). Where possible, patients will check into the clinic on Day -1, the evening prior to dosing (Day 1), and remain resident until 24 hours after the dose of osimertinib (Day 2) for collection of blood samples and 24-hour pooled urine for PK analysis during this time. Samples will be analysed to determine the concentrations of osimertinib and metabolites (AZ5104 and AZ7550) in plasma, urine, and plasma ultrafiltrate (PUF). Patients will then return to the clinic as outpatients for assessments on Day 3 (48 hours), Day 4 (72 hours), Day 6 (120 hours), Day 8 (168 hours) and Day 10 (216 hours).
Part B will allow patients with severe renal impairment, who complete Part A, to continue to receive osimertinib 80 mg once daily for 12 weeks and will provide additional safety data. Patients should start Part B after the last PK sample collected in Part A (ie, 216 hours after receiving the single dose of osimertinib in Part A).
If a patient does not immediately continue into Part B, this should be discussed on a case by case basis with the AstraZeneca physician or representative. Patients who enter Part B, will have weekly clinic visits for the first 3 weeks; thereafter visits will be every 3 weeks until Week 12. Safety assessments will be collected and there will be no formal evaluation of efficacy.
At the end of Part B, those patients with severe renal impairment who are deemed to be gaining clinical benefit from osimertinib will enter the continued access phase. Patients with normal renal function can enter the continued access phase immediately after completing Part A (ie, collection of the last PK sample scheduled on Day 10 of Part A). During the continued access phase, patients may continue to take osimertinib 80 mg once daily, if patients and the Investigator deem it appropriate, or until such time as their disease progresses, the Investigator believes the patients are no longer deriving clinical benefit, or patients stop taking osimertinib for any other reason. No clinical data, other than serious adverse events (SAEs) that may be related to the investigational product (IP), will be collected during this phase.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Angers Cedex 2, France, 49055
- Research Site
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Bordeaux, France, 33000
- Research Site
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Dijon, France, 21079
- Research Site
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Lille Cedex, France, 59020
- Research Site
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Saint Herblain, France, 44805
- Research Site
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Seoul, Korea, Republic of, 05505
- Research Site
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Seoul, Korea, Republic of, 03080
- Research Site
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Madrid, Spain, 28046
- Research Site
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Madrid, Spain, 28040
- Research Site
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Madrid, Spain, 28050
- Research Site
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Sevilla, Spain, 41013
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- For inclusion as a patient with severe renal impairment patient must have stable severe renal impairment (CrCl <30 mL/min at screening), for at least 2 months prior to the study.
- For inclusion as a patient with normal renal function, patient must have CrCl ≥90 mL/min at screening.
- >18 years old
- Histological or cytological confirmation of a solid, malignant tumour (excluding lymphoma) that is refractory to standard therapies or for which no standard therapies exist. Tumours in which inhibition of the EGFR pathway is considered relevant by the Investigator are not mandated but are encouraged.
- ECOG performance status ≤2
- Life expectancy of ≥12 weeks
- BMI 18-35.
- Females should be using adequate contraceptive measures and must have a negative pregnancy test prior to dosing if of child-bearing potential or must have evidence of non-child bearing potential
- Males should use barrier contraception until 6 months after the last study drug is taken.
Exclusion criteria
- Participation in another clinical study with an IP during the last 14 days (or a longer period, depending on the agents used).
Treatment with any of the following:
- Treatment with a 1st or 2nd generation EGFR-TKI within 8 days or approximately 5 half-lives, prior to the first dose of study drug.
- Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 14 days of the first dose of study drug.
- Osimertinib in the present study or has previously received a 3rd generation EGFR-TKI (eg, CO 1686).
- Major surgery within 4 weeks of the first dose of study drug.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment
- Currently receiving medications or herbal supplements known to be potent inducers of CYP3A4. Patients in Part B and continued access must avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer effects on CYP3A4.
- Patients with severe renal impairment only: use of concurrent medication known to affect CrCl within 7 days of the first dose
- Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment; with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy
- Spinal cord compression or brain metastases, unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count <1.5 x 109/L
- Platelet count <100 x 109/L
- Haemoglobin <90 g/L
- ALT >2.5 times the ULN if no demonstrable liver metastases or >5xULN in the presence of liver metastases
- AST >2.5xULN if no demonstrable liver metastases or > 5xULN in the presence of liver metastases
- Total bilirubin >1.5 times ULN if no liver metastases or >3xULN in the presence of liver metastases
Any of the following cardiac criteria:
- Mean resting QT interval QTcF >470 msec, obtained from 3 ECGs.
- Abnormalities in rhythm, conduction or morphology of resting ECG
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
- Unable to swallow oral medication or patients with GI disorders or significant GI resection.
- Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- Severe portal hypertension or surgical porto-systemic shunts.
- Kidney transplant
- On dialysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Normal renal function
For inclusion in the study as a patient with normal renal function, patients must have creatinine clearance ≥90 mL/min.
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80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit
Other Names:
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Experimental: Severe renal impairment
For inclusion in the study as a patient with severe renal impairment, patients must have stable severe renal impairment (creatinine clearance <30 mL/min), as defined by the Cockcroft Gault equation, for at least 2 months prior to Day 1.
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80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration-time curve from zero to infinity for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose
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Part A: To investigate the PK of osimertinib after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose
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Maximum plasma concentration for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose
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Part A: To investigate the PK of osimertinib after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration-time curve from zero to the last quantifiable time point for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Area under the plasma concentration-time curve from zero to 24 hours post-dose for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs for osimertinib post-dose
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs for osimertinib post-dose
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Time to maximum plasma concentration for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Apparent clearance following oral administration for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Apparent volume of distribution for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Terminal rate constant for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Terminal half-life for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Amount excreted in urine from time zero to 24 hours post-dose for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs for osimertinib post-dose
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs for osimertinib post-dose
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Renal clearance for osimertinib
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs post-dose for osimertinib plasma and 24 hour urine collection.
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Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs post-dose for osimertinib plasma and 24 hour urine collection.
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Maximum plasma concentration for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Maximum plasma concentration for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Time to maximum plasma concentration for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Time to maximum plasma concentration for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Area under the plasma concentration time curve from zero to infinity for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Area under the plasma concentration time curve from zero to infinity for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Area under the plasma concentration-time curve from zero to the last quantifiable time point for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Area under the plasma concentration-time curve from zero to the last quantifiable time point for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Amount excreted in urine from time zero to 24 hours post-dose for AZ5104
Time Frame: 24 hour pooled collection starting from time of dosing on Day 1
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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24 hour pooled collection starting from time of dosing on Day 1
|
Amount excreted in urine from time zero to 24 hours post-dose for AZ7550
Time Frame: 24 hour pooled collection starting from time of dosing on Day 1
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
24 hour pooled collection starting from time of dosing on Day 1
|
Terminal rate constant for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Terminal rate constant for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Terminal half-life for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Terminal half-life for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Renal clearance for AZ5104
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs post-dose for AZ5104 plasma and 24 hour urine collection.
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24hrs post-dose for AZ5104 plasma and 24 hour urine collection.
|
Renal clearance for AZ7550
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24 hours post-dose for AZ7550 plasma and 24 hour urine collection.
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24 hours post-dose for AZ7550 plasma and 24 hour urine collection.
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Metabolite to parent ratios for maximum plasma concentration
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
|
On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Metabolite to parent ratios for area under the plasma concentration time curve from zero to infinity
Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
|
Part A: To investigate the PK of osimertinib and metabolites (AZ5104 and AZ7550) after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
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On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs for osimertinib post-dose
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Part A: Adverse Events's, graded by the National Cancer Institute Common Terminology Criteria for Adverse Event's (CTCAE v4.0)
Time Frame: Until 30 days following the final dose of osimertinib
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Part A: To investigate the safety and tolerability of a single oral dose of osimertinib in patients with advanced solid tumours and normal renal function or severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part A: physical exam
Time Frame: Until 30 days following the final dose of osimertinib
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Part A: To investigate the safety and tolerability of a single oral dose of osimertinib in patients with advanced solid tumours and normal renal function or severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part A: vital signs
Time Frame: Until 30 days following the final dose of osimertinib
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Part A: To investigate the safety and tolerability of a single oral dose of osimertinib in patients with advanced solid tumours and normal renal function or severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part A: ECG
Time Frame: Until 30 days following the final dose of osimertinib
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Part A: To investigate the safety and tolerability of a single oral dose of osimertinib in patients with advanced solid tumours and normal renal function or severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part A: evaluation of laboratory
Time Frame: Until 30 days following the final dose of osimertinib
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Part A: To investigate the safety and tolerability of a single oral dose of osimertinib in patients with advanced solid tumours and normal renal function or severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part A: echocardiogram/MUGA.
Time Frame: Until 30 days following the final dose of osimertinib
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Part A: To investigate the safety and tolerability of a single oral dose of osimertinib in patients with advanced solid tumours and normal renal function or severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part B - Adverse events, graded CTCAE v4.0
Time Frame: Until 30 days following the final dose of osimertinib
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Part B: To investigate the safety and tolerability of multiple oral doses of osimertinib in patients with advanced solid tumours and severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part B -physical exam
Time Frame: Until 30 days following the final dose of osimertinib
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Part B: To investigate the safety and tolerability of multiple oral doses of osimertinib in patients with advanced solid tumours and severe renal impairment.
|
Until 30 days following the final dose of osimertinib
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Part B - vital signs
Time Frame: Until 30 days following the final dose of osimertinib
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Part B: To investigate the safety and tolerability of multiple oral doses of osimertinib in patients with advanced solid tumours and severe renal impairment.
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Until 30 days following the final dose of osimertinib
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Part B - ECG
Time Frame: Until 30 days following the final dose of osimertinib
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Part B: To investigate the safety and tolerability of multiple oral doses of osimertinib in patients with advanced solid tumours and severe renal impairment.
|
Until 30 days following the final dose of osimertinib
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Part B - evaluation of laboratory parameters.
Time Frame: Until 30 days following the final dose of osimertinib
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Part B: To investigate the safety and tolerability of multiple oral doses of osimertinib in patients with advanced solid tumours and severe renal impairment.
|
Until 30 days following the final dose of osimertinib
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe Ravaud, MD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5160C00035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumours
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Royal Marsden NHS Foundation TrustInstitute of Cancer Research, United Kingdom; Onyx Therapeutics, Inc.Completed
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Debiopharm International SATerminatedSolid TumoursKorea, Republic of, United States, Taiwan, Spain, Singapore
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AstraZenecaCompleted
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AstraZenecaCompleted
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AstraZenecaParexelCompleted
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AstraZenecaQuintiles, Inc.Completed
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AstraZenecaRecruitingSolid TumoursAustralia, Korea, Republic of, Germany, United States, Spain, France, Canada, Italy, Austria, Israel, United Kingdom, Denmark, Hungary, Poland, Russian Federation, Ukraine, Brazil
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AstraZenecaCompletedSolid TumoursUnited States, Spain, Belgium, France, Korea, Republic of, United Kingdom
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AstraZenecaCompletedSolid TumoursBelgium, United Kingdom, Netherlands
Clinical Trials on Osimertinib; AZD9291
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AstraZenecaCompletedNon-small Cell Lung CancerSweden
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AstraZenecaTerminated
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AstraZenecaCompleted
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AstraZenecaActive, not recruitingAdvanced Non Small Cell Lung CancerCanada, Poland, Taiwan, United States, Korea, Republic of, Japan, Russian Federation, Ukraine
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AstraZenecaParexelActive, not recruitingNon-small Cell Lung CancerItaly, Spain, United States, China, Germany, Israel
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AstraZenecaActive, not recruitingStage IB-IIIA Non-small Cell Lung CarcinomaUnited States, Italy, Netherlands, Belgium, Canada, Poland, Romania, Taiwan, Thailand, Vietnam, France, Brazil, Hungary, Japan, Russian Federation, Turkey, China, Korea, Republic of, Germany, Hong Kong, Spain, Australia, Israel, Ukraine, Swed...
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AstraZenecaCompletedCarcinoma, Non-Small-Cell Lung With EGFR Mutation PositiveChina
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Samsung Medical CenterActive, not recruitingNon-Small Cell Lung Cancer With EGFR T790M Mutation | With Brain and/or Leptomeningeal Metastasis | Failed Tyrosine Kinase InhibitorsKorea, Republic of
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Chonnam National University HospitalCompletedLung Neoplasms | EGFR Gene MutationsKorea, Republic of
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Ascentage Pharma Group Inc.Suzhou Yasheng Pharmaceutical Co., Ltd.RecruitingEGFR Positive Non-small Cell Lung CancerChina