CancerPhase 2ASPIDIANCT02323516
Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
A Phase 2 study testing Acetylsalicylic acid + loperamide and diosmectite + loperamide in people with Cancer, run by Centre Francois Baclesse at 5 sites in France.
Trial summary
The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin… Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Cancer
- What is being tested?
- Acetylsalicylic acid + loperamide and diosmectite + loperamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 2
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged at least 18 years old patient;
- WHO 0 to 2;
- Any solid tumor or hematologic malignancy requiring a tyrosine kinase inhibitor prescription in the absence of digestive disorders related to tumor disease;
- Treatment with one of the following targeted therapies: Gefitinib, erlotinib, sunitinib, sorafenib, Axitinib, Pazopanib, Lapatinib, Imatinib, afatinib,vemurafenib and Dabrafenib;
- Targeted therapy treatment whatever the processing line monotherapy, administered over a period of at least 15 days with continued dosing, with usual care recommendations;
- Diarrhea grade 1-3 according to NCI criteria CTCAE.4, in the absence of complications signs with at least 2 doses of loperamide per day.
Who cannot join
- Processing acetylsalicylic acid;
- Allergy or against-indications to acetylsalicylic acid (including concomitant antiplatelet or anticoagulant considered as increasing the risk of bleeding by the investigator) acid;
- Treatment with anti vitamin K or new oral anticoagulants;
- Absolute in pursuit of targeted therapy contraindication;
- Chronic diarrhea prior to clinical introduction of targeted therapy;
- Diarrhoea unrelated to targeted therapy such as:
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- extended resection of esophagus, inflammatory bowel disease, etc ...
- carcinoid syndrome;
- occlusive syndrome;
- Grade 3 diarrhea with signs of complications or grade 4
- Patients with a history of grade 3 diarrhea with signs of complications or grade 4 during previous treatment with TKI;
- Participation in other medical test;
- Pregnant women / nursing;
- Association with methotrexate at doses > 15 mg / d;
- Patient Trust or deprived of liberty.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU
Amiens
Centre François Baclesse
Caen, 14076
Centre Hospitalier public du Cotentin
Cherbourg, 50100
Centre hospitalier
Compiègne
Centre Léon Bérard
Lyon
About this study
The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation.
The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells.
Read more
The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies.
Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib.
In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.
- Conditions
- Cancer
- Being tested
- Acetylsalicylic acid + loperamide, diosmectite + loperamide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid + loperamideDrug
In case of inefficiency in one month, according to predefined criteria, acetylsalicylic acid will be stopped and replaced by diosmectite.
diosmectite + loperamideDrug
In case of inefficiency in one month, according to predefined criteria, diosmectite will be stopped and replaced by acetylsalicylic acid.
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic acid + loperamide | Experimental | Acetylsalicylic acid + loperamide Receives: Drug: diosmectite + loperamide |
| diosmectite + loperamide | Active comparator | Acetylsalicylic acid + loperamide Receives: Drug: Acetylsalicylic acid + loperamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy measured by the decrease in the intensity of diarrhea and / or anti-diarrheal consumption
Effectiveness of acetylsalicylic acid versus diosmectite
Measured: 1 month
Secondary outcomes (4)
Toxicity
Diarrhea decrease 3 months after the introduction of acetylsalicylic acid or diosmectite; Proportion of patients with a decrease in the grade of diarrhea during the months following the introduction of acetylsalicylic acid or diosmectite. Rate and intensity of side effects associated with other targeted therapy.
Measured: Three months
TKI dose reduction
Proportion of patients requiring dose reduction of targeted therapy
Measured: Three months
Quality of life
Quality of life and its evolution by month using ladders FACIT-G and FACIT-D.
Measured: Three months
Safety measured by the proportion of adverse event
Safety of acetylsalicylic acid in patients with diarrhea in targeted therapy
Measured: Months 1 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France, Canceropôle Nord Ouest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323516
- Sponsor's protocol ID
- ASPIDIA
- Acronym
- ASPIDIA
- Status last verified
- Dec 2015
- First submitted
- 19 Nov 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
- ClinicalTrials.gov ID
- NCT02323516
- Acronym / sponsor ID
- ASPIDIA / ASPIDIA
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France, Canceropôle Nord Ouest
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Dec 2014 (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.
The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation.
The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells.
The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies.
Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib.
In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic acid + loperamide | Experimental | Drug: diosmectite + loperamideAcetylsalicylic acid + loperamide |
| diosmectite + loperamide | Active comparator | Drug: Acetylsalicylic acid + loperamideAcetylsalicylic acid + loperamide |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged at least 18 years old patient;
- WHO 0 to 2;
- Any solid tumor or hematologic malignancy requiring a tyrosine kinase inhibitor prescription in the absence of digestive disorders related to tumor disease;
- Treatment with one of the following targeted therapies: Gefitinib, erlotinib, sunitinib, sorafenib, Axitinib, Pazopanib, Lapatinib, Imatinib, afatinib,vemurafenib and Dabrafenib;
- Targeted therapy treatment whatever the processing line monotherapy, administered over a period of at least 15 days with continued dosing, with usual care recommendations;
Key exclusion criteria (15 listed)
- Processing acetylsalicylic acid;
- Allergy or against-indications to acetylsalicylic acid (including concomitant antiplatelet or anticoagulant considered as increasing the risk of bleeding by the investigator) acid;
- Treatment with anti vitamin K or new oral anticoagulants;
- Absolute in pursuit of targeted therapy contraindication;
- Chronic diarrhea prior to clinical introduction of targeted therapy;
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 |
|---|---|---|
| Acetylsalicylic acid + loperamideIn case of inefficiency in one month, according to predefined criteria, acetylsalicylic acid will be stopped and replaced by diosmectite. | Drug | diosmectite + loperamide |
| diosmectite + loperamideIn case of inefficiency in one month, according to predefined criteria, diosmectite will be stopped and replaced by acetylsalicylic acid. | Drug | Acetylsalicylic acid + loperamide |
Primary outcome
Efficacy measured by the decrease in the intensity of diarrhea and / or anti-diarrheal consumption
Time frame: 1 month
Effectiveness of acetylsalicylic acid versus diosmectite
4 secondary outcomes
Toxicity
Time frame: Three months
TKI dose reduction
Time frame: Three months
Quality of life
Time frame: Three months
Safety measured by the proportion of adverse event
Time frame: Months 1 to 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetylsalicylic acid + loperamide and diosmectite + loperamide in people with Cancer, run by Centre Francois Baclesse at 5 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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy measured by the decrease in the intensity of diarrhea and / or anti-diarrheal consumption (time frame: 1 month). 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 8 Dec 2015.