Non-small Cell Lung CancerPhase 4PKAPIRNCT03607149
Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies
A Phase 4 study testing Pemetrexed in people with Non-small Cell Lung Cancer, run by Centre Georges Francois Leclerc at 3 sites in France.
Trial summary
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Apr 2017to 20 Feb 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented
- Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed
- Neutrophils> 1500 / mm3; Chips> 100,000 / mm3
- Informed, dated and signed consent For patients of childbearing age, effective contraceptive method
- Creatinine clearance according to the Cockcroft-Gault formula between 70 and 45 mL / min
- PS = 0 or 1
Who cannot join
- Patient with a contraindication to pemetrexed therapy
- Patient with symptomatic brain metastases
- Pregnant or nursing women
- Patient under guardianship or curatorship or subject to a system of protection for persons of full age
- Patient not affiliated to a social security scheme (beneficiary or beneficiary)
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH William Morey
Chalon-sur-Saône, 71100
Centre Georges Francois Leclerc
Dijon, 21079
Centre Universitaire Hospitalier de Dijon
Dijon, 21079
About this study
Official title: Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.
The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.
Read the detailed description
- Primary objective: Evaluate the impact of calculating the dose of pemetrexed to be administered versus creatine clearance according to Cockcroft-Gault (CrCLCG) versus body surface area (SC) on median time before discontinuation of treatment for renal function ≤ 45mL / min in patients treated for non-small cell lung cancer predominantly non-squamous in maintenance.
- Secondary objective: To evaluate the impact of calculating the dose of pemetrexed to be administered versus CRCLCG versus SC over time to treatment discontinuation, progression-free survival (PFS), and patient overall survival.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pemetrexed
- Keywords
- Pemetrexed, Non-small cell lung cancer, Clearance of creatine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
standard arm : calculating the dose of pemetrexed according to body surface area
experimental arm: calculation of the dose of pemetrexed as a function of creatinine clearance (CrCLCG)
| Study group | Role | What they receive |
|---|---|---|
| STANDARD ARM | Active comparator | Calculation of the dose of pemetrexed as a function of body surface area Receives: Drug: Pemetrexed |
| EXPERIMENTAL ARM | Experimental | Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG) Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time until treatment is stopped due to renal function ≤ 45mL / min
From date of randomization until the date of treatment is stopped
Measured: 1 year
Secondary outcomes (1)
Progression-free survival
From date of randomization until the date of death from any cause
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start6 Apr 2017
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607149
- Sponsor's protocol ID
- 2016-002552-24
- Other IDs
- 2016
- Acronym
- PKAPIR
- Status last verified
- May 2021
- First submitted
- 21 Jun 2017
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)
- ClinicalTrials.gov ID
- NCT03607149
- Acronym / sponsor ID
- PKAPIR / 2016-002552-24
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Pemetrexed, Non-small cell lung cancer, Clearance of creatine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 31 Jul 2018 (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.
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.
The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.
Detailed description
- Primary objective: Evaluate the impact of calculating the dose of pemetrexed to be administered versus creatine clearance according to Cockcroft-Gault (CrCLCG) versus body surface area (SC) on median time before discontinuation of treatment for renal function ≤ 45mL / min in patients treated for non-small cell lung cancer predominantly non-squamous in maintenance.
- Secondary objective: To evaluate the impact of calculating the dose of pemetrexed to be administered versus CRCLCG versus SC over time to treatment discontinuation, progression-free survival (PFS), and patient overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD ARM | Active comparator | Drug: PemetrexedCalculation of the dose of pemetrexed as a function of body surface area |
| EXPERIMENTAL ARM | Experimental | Drug: PemetrexedCalculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18 years of age
- Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented
- Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed
- Neutrophils> 1500 / mm3; Chips> 100,000 / mm3
- Informed, dated and signed consent For patients of childbearing age, effective contraceptive method
Key exclusion criteria (5 listed)
- Patient with a contraindication to pemetrexed therapy
- Patient with symptomatic brain metastases
- Pregnant or nursing women
- Patient under guardianship or curatorship or subject to a system of protection for persons of full age
- Patient not affiliated to a social security scheme (beneficiary or beneficiary)
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 |
|---|---|---|
| Pemetrexedstandard arm : calculating the dose of pemetrexed according to body surface area experimental arm: calculation of the dose of pemetrexed as a function of creatinine clearance (CrCLCG) | Drug | EXPERIMENTAL ARM, STANDARD ARM |
Primary outcome
Median time until treatment is stopped due to renal function ≤ 45mL / min
Time frame: 1 year
From date of randomization until the date of treatment is stopped
1 secondary outcome
Progression-free survival
Time frame: up to 100 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pemetrexed in people with Non-small Cell Lung Cancer, run by Centre Georges Francois Leclerc at 3 sites in France.
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 7 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: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time until treatment is stopped due to renal function ≤ 45mL / min (time frame: 1 year). 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 24 May 2021.