Liver DiseasesNCT04863144
Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
An observational study of Liver Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Blood samples
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 Patients with histologically confirmed solid tumors and are going to receive paclitaxel
Who may be able to join
- Patients with histologically proven non haematopoietic malignancy (ovarian, breast and lung cancer).
- Age between 18 and 70 years
- At least a 4-week interval between the last dose of previous chemotherapy protocol and registration (6 weeks in case of treatment with carboplatin).
- Glomerular filtration rate > 60 ml/min
- An Eastern Cooperative Oncology Group performance status 0-2, a life expectancy of > 12 weeks, adequate bone marrow function [absolute neutrophil count (ANC) ≥ 1 X 109 and platelets ≥ 100 X 109]
- Patient accessible for treatment and follow-up and written informed consent.
Who cannot join
- Prior treatment with paclitaxel or other taxanes.
- Pre-existing motor or sensory neurotoxicity > grade 2 according to World Health Organization (WHO) criteria.
- Active infection or other serious underlying medical condition (including prior allergic reactions to Paclitaxel or the drug's constituents), dementia or significantly altered mental status, symptomatic brain or liver metastases, history of atrial or ventricular arrhythmias or congestive heart failure even if medically controlled, history of clinical and electrocardiographically documented myocardial infarction.
- Simultaneous use of any medication, dietary supplements, or other compounds known to inhibit affect the pharmacokinetics of paclitaxel.
- Patients with difficult blood sampling.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El Demerdash Oncology Hospital
Cairo, Abbasia, 11865
Ahmed M Mohamed, Master, 01126109080, dr_ahmed_mostafa@med.asu.edu.eg
About this study
Official title: Effect of CYP3A4 and CYP2C8 Activity on Pharmacokinetics of Paclitaxel, Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.
Read the detailed description
population pharmacokinetic study in patients with normal or impaired liver functions, receiving paclitaxel for cancer treatment.
40 Patients with histologically confirmed solid tumors will be enrolled in the study:
- 20 patients have normal liver functions as defined by transaminase < 2.6 x ULN and bilirubin values < 1.26 x ULN.
- 20 patients with liver impairment as defined by transaminase 2.6 - 10 x ULN and bilirubin values 1.26 - 5 x ULN.
- Conditions
- Liver Diseases
- Being tested
- Blood samples
- Keywords
- Paclitaxel, Pharmacokinetics, Egypt
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Plasma concentrations of paclitaxel and its metabolites will be obtained during the first treatment cycle. The samples for paclitaxel analysis will be collected in ethylenediamine tetraacetic acid tubes at 7-time points: just before infusion, in the middle of the infusion, at the end of infusion, at 1, 2, 4 and 6 hours post-infusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of paclitaxel
determination of plasma concentration and pharmacokinetic analysis of paclitaxel
Measured: predose till 6 hours post infusion of paclitaxel
plasma concentrations of 6-α-hydroxypaclitaxel
determination of plasma concentration and pharmacokinetic analysis of 6-α-hydroxypaclitaxel
Measured: predose till 6 hours post infusion of paclitaxel
plasma concentrations of 3'-p-hydroxypaclitaxel
determination of plasma concentration and pharmacokinetic analysis of 3'-p-hydroxypaclitaxel
Measured: predose till 6 hours post infusion of paclitaxel
Secondary outcomes (3)
Probing CYP 3A4 activity
metabolite ratio of 6-α-hydroxypaclitaxel/paclitaxel
Measured: predose till 6 hours post infusion of paclitaxel
Probing CYP 2C8 activity
metabolite ratio of 3'-p-hydroxypaclitaxel/paclitaxel
Measured: predose till 6 hours post infusion of paclitaxel
Incidence of adverse effects
Complete blood count, liver functions and neuropathy evaluation (according to Common Terminology Criteria for Adverse Events (CTCAE), version 5) will be assessed
Measured: baseline ( before first dose) till 100 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Aug 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Nour-Eldin, Professor, Study director, Pharmacology Department - Faculty of Medicine - Ain Shams UniversityKhaled Abdel-Aziz, MD, Study director, Oncology Department - Faculty of Medicine - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863144
- Sponsor's protocol ID
- FMASU MD 8/2020
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CYP3A4 and CYP2C8 Activity on Pharmacokinetics of Paclitaxel, Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
- ClinicalTrials.gov ID
- NCT04863144
- Acronym / sponsor ID
- FMASU MD 8/2020
- Conditions
- Liver Diseases
- Keywords
- Paclitaxel, Pharmacokinetics, Egypt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.
Detailed description
population pharmacokinetic study in patients with normal or impaired liver functions, receiving paclitaxel for cancer treatment.
40 Patients with histologically confirmed solid tumors will be enrolled in the study:
- 20 patients have normal liver functions as defined by transaminase < 2.6 x ULN and bilirubin values < 1.26 x ULN.
- 20 patients with liver impairment as defined by transaminase 2.6 - 10 x ULN and bilirubin values 1.26 - 5 x ULN.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 Patients with histologically confirmed solid tumors and are going to receive paclitaxel
Key inclusion criteria (6 listed)
- Patients with histologically proven non haematopoietic malignancy (ovarian, breast and lung cancer).
- Age between 18 and 70 years
- At least a 4-week interval between the last dose of previous chemotherapy protocol and registration (6 weeks in case of treatment with carboplatin).
- Glomerular filtration rate > 60 ml/min
- An Eastern Cooperative Oncology Group performance status 0-2, a life expectancy of > 12 weeks, adequate bone marrow function [absolute neutrophil count (ANC) ≥ 1 X 109 and platelets ≥ 100 X 109]
Key exclusion criteria (5 listed)
- Prior treatment with paclitaxel or other taxanes.
- Pre-existing motor or sensory neurotoxicity > grade 2 according to World Health Organization (WHO) criteria.
- Active infection or other serious underlying medical condition (including prior allergic reactions to Paclitaxel or the drug's constituents), dementia or significantly altered mental status, symptomatic brain or liver metastases, history of atrial or ventricular arrhythmias or congestive heart failure even if medically controlled, history of clinical and electrocardiographically documented myocardial infarction.
- Simultaneous use of any medication, dietary supplements, or other compounds known to inhibit affect the pharmacokinetics of paclitaxel.
- Patients with difficult blood sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesPlasma concentrations of paclitaxel and its metabolites will be obtained during the first treatment cycle. The samples for paclitaxel analysis will be collected in ethylenediamine tetraacetic acid tubes at 7-time points: just before infusion, in the middle of the infusion, at the end of infusion, at 1, 2, 4 and 6 hours post-infusion. | Other | – |
Primary outcome
plasma concentrations of paclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
determination of plasma concentration and pharmacokinetic analysis of paclitaxel
plasma concentrations of 6-α-hydroxypaclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
determination of plasma concentration and pharmacokinetic analysis of 6-α-hydroxypaclitaxel
plasma concentrations of 3'-p-hydroxypaclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
determination of plasma concentration and pharmacokinetic analysis of 3'-p-hydroxypaclitaxel
3 secondary outcomes
Probing CYP 3A4 activity
Time frame: predose till 6 hours post infusion of paclitaxel
Probing CYP 2C8 activity
Time frame: predose till 6 hours post infusion of paclitaxel
Incidence of adverse effects
Time frame: baseline ( before first dose) till 100 days after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Nour-Eldin, Professor study director
Pharmacology Department - Faculty of Medicine - Ain Shams University
Khaled Abdel-Aziz, MD study director
Oncology Department - Faculty of Medicine - Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Mohamed, Master (01126109080, dr_ahmed_mostafa@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentrations of paclitaxel (time frame: predose till 6 hours post infusion of paclitaxel). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.