CancerTKI-CPKNCT01248429
Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases
An observational study of Cancer and Solid Tumor, run by Centre Oscar Lambret at 27 sites in France.
Trial summary
This study describes the elevation of CPK in patient treated for solid tumors by TKI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor
- What is being tested?
- CPK dosage and Clinical exam
- How many people
- 154 participants
- Where
- 27 sitesFrance
- Study dates
- Nov 2010to 15 Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for a solid tumor by thyrosin kinase inhibitors
Who may be able to join
- Patients with solid tumor treated by inhibitor of tyrosin kinase for at least 1 week
- Patient examined AND with a routine blood test planned
- Patient informed of procedure for the study who was not opposed to it
Who cannot join
- Patient treated for malignant hemopathy
- Patient no treated by inhibitor of thyrosine kinase or for less than 1 week
- Patients with no routine blood laboratory tests planned
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Centre Paul Papin
Angers, 49000
Hôpital Jean Minjoz
Besançon, 25030
CHU Bordeaux
Bordeaux, 33076
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Hôpital Henri Mondor - APHP
Créteil, 94010
Centre Oscar Lambret
Lille, 59020
CHU Limoges
Limoges, 87042
Hôpital Edouard Herriot
Lyon, 69003
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Hôpital Saint-Louis - APHP
Paris, 75010
Hôpital Cochin - APHP
Paris, 75014
Hôpital Tenon - APHP
Paris, 75020
Institut Curie
Paris, 75248
Institut Jean Godinot
Reims, 51056
CHU Robert Debré
Reims, 51092
Centre Eugène Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76000
Centre René Huguenin
Saint-Cloud, 92211
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
Institut Claudius Régaud
Toulouse, 31052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)
This study describes the elevation of CPK in patient treated for solid tumors by TKI
- Conditions
- Cancer, Solid Tumor
- Being tested
- CPK dosage, Clinical exam
- Keywords
- thyrosine kinase inhibitor, phosphokinase creatinin, myalgia
- Medical subject headings
- Neoplasms, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPK dosageBiological
CPK dosage during a blood sample realized at least one week after the begining of the treatment
Clinical examOther
Examination of the patient for myalgia, cramps, medical history and concomitant medication
| Study group | Role | What they receive |
|---|---|---|
| Patient treated by TKI | Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week Receives: Biological: CPK dosage; Other: Clinical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of the CPK increase
Dosage of CPK during standard blood sampling. The increase of CPK is defined when CPK value > USL
Measured: Within 3 days after a clinical exam
Secondary outcomes (1)
Correlation myalgia/CPK increase
To determine the correlation between myalgia and CPK blood, taking into account the risk factors leading to CPK increase
Measured: During the clinical exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completion15 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ADENIS, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248429
- Sponsor's protocol ID
- TKI-CPK-1003
- Acronym
- TKI-CPK
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2010
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)
- ClinicalTrials.gov ID
- NCT01248429
- Acronym / sponsor ID
- TKI-CPK / TKI-CPK-1003
- Conditions
- Cancer, Solid Tumor
- Keywords
- thyrosine kinase inhibitor, phosphokinase creatinin, myalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- 15 Jan 2013 (actual)
- First posted
- 25 Nov 2010 (estimated)
- 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.
This study describes the elevation of CPK in patient treated for solid tumors by TKI
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated by TKI | – | Biological: CPK dosage, Other: Clinical examAny patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for a solid tumor by thyrosin kinase inhibitors
Key inclusion criteria (3 listed)
- Patients with solid tumor treated by inhibitor of tyrosin kinase for at least 1 week
- Patient examined AND with a routine blood test planned
- Patient informed of procedure for the study who was not opposed to it
Key exclusion criteria (3 listed)
- Patient treated for malignant hemopathy
- Patient no treated by inhibitor of thyrosine kinase or for less than 1 week
- Patients with no routine blood laboratory tests planned
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 |
|---|---|---|
| CPK dosageCPK dosage during a blood sample realized at least one week after the begining of the treatment | Biological | Patient treated by TKI |
| Clinical examExamination of the patient for myalgia, cramps, medical history and concomitant medication | Other | Patient treated by TKI |
Primary outcome
To evaluate the prevalence of the CPK increase
Time frame: Within 3 days after a clinical exam
Dosage of CPK during standard blood sampling. The increase of CPK is defined when CPK value > USL
1 secondary outcome
Correlation myalgia/CPK increase
Time frame: During the clinical exam
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 16 Mar 2026.
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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.
Antoine ADENIS, MD, PhD principal investigator
Centre Oscar Lambret
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor, run by Centre Oscar Lambret at 27 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 3 inclusion and 3 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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.
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?
To evaluate the prevalence of the CPK increase (time frame: Within 3 days after a clinical exam). 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 16 Mar 2026.