Metastatic Colorectal CancerPhase 2NCT03274882
Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies
A Phase 2 study testing S95005 in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 2 sites in Russia.
Trial summary
The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- S95005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesRussia
- Study dates
- 3 Mar 2017to 3 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years of age
- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies
- Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Has at least one measurable metastatic lesion(s)
- Has adequate organ function
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication
Who cannot join
- Pregnancy, breastfeeding
- Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed
- Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005
- Has a serious illness or medical condition(s) as described in the protocol
- Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
Moscow, 115478
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Saint Petersburg, 197758
About this study
Official title: Open-label Multicentre Confirmatory Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapies
The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- S95005
- Keywords
- metastatic, colorectal, cancer, Lonsurf, S95005, Russia
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S95005Drug
Also called TAS-102
The treatment is given in open manner. It was administered until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. If a patient discontinues study treatment for reasons other than radiologic disease progression (e.g., intolerable side effects), the patient was followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| S95005 | Experimental | Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio of 1:0.5) was administered at 35 mg/m²/dose orally twice a day, within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period. This treatment cycle was repeated every 4 weeks until treatment withdrawal criteria are met. Receives: Drug: S95005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) rate
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
Measured: at 2 months
Secondary outcomes (12)
Progression-Free Survival (PFS).
based on Investigator review of the images according to RECIST 1.1
Measured: Through study completion, an average of 12 weeks
Overall Response Rate (ORR).
based on Investigator review of the images according to RECIST 1.1
Measured: Through study completion, an average of 12 weeks
Disease Control Rate (DCR)
based on Investigator review of the images according to RECIST 1.1
Measured: Through study completion, an average of 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in physical examination and performance status (ECOG) [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in blood pressure [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in heart rate [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in body temperature [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in respiration rate [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in body weight [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Abnormalities in 12-leads ECG parameters [safety and tolerability]
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start3 Mar 2017
- Primary completion31 Dec 2017
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
- Investigators
- Vladimir MOISEENKO, Prof., Principal investigator, Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274882
- Sponsor's protocol ID
- CL2-95005-003
- Other IDs
- ISRCTN14228310
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2017
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Publications
Fedyanin M, Chekini D, Chubenko V, Tjulandin S, Zhabina A, Amellal N, Aubel P, Gandossi E, Moiseenko V. Trifluridine/tipiracil safety and efficacy in Russian patients with metastatic colorectal cancer and refractory or intolerant to standard chemotherapies: Results of the primary analysis. Ann Oncol. 2019 Jul;30(Supplement 4):IV16. doi: 10.1093/annonc/mdz155.057
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Multicentre Confirmatory Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapies
- ClinicalTrials.gov ID
- NCT03274882
- Acronym / sponsor ID
- CL2-95005-003
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic, colorectal, cancer, Lonsurf, S95005, Russia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 7 Sep 2017 (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 purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S95005 | Experimental | Drug: S95005Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio of 1:0.5) was administered at 35 mg/m²/dose orally twice a day, within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period. This treatment cycle was repeated every 4 weeks until treatment withdrawal criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥18 years of age
- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies
- Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Has at least one measurable metastatic lesion(s)
Key exclusion criteria (6 listed)
- Pregnancy, breastfeeding
- Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed
- Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005
- Has a serious illness or medical condition(s) as described in the protocol
- Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
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 |
|---|---|---|
| S95005Also: TAS-102The treatment is given in open manner. It was administered until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. If a patient discontinues study treatment for reasons other than radiologic disease progression (e.g., intolerable side effects), the patient was followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first). | Drug | S95005 |
Primary outcome
Progression free survival (PFS) rate
Time frame: at 2 months
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
12 secondary outcomes
Progression-Free Survival (PFS).
Time frame: Through study completion, an average of 12 weeks
Overall Response Rate (ORR).
Time frame: Through study completion, an average of 12 weeks
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in physical examination and performance status (ECOG) [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in blood pressure [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in heart rate [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in body temperature [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in respiration rate [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in body weight [safety and tolerability]
Time frame: Through study completion, an average of 12 weeks
Abnormalities in 12-leads ECG parameters [safety and tolerability]
Time frame: Through study completion, an average of 12 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 25 Jul 2024.
- BackgroundFedyanin M, Chekini D, Chubenko V, Tjulandin S, Zhabina A, Amellal N, Aubel P, Gandossi E, Moiseenko V. Trifluridine/tipiracil safety and efficacy in Russian patients with metastatic colorectal cancer and refractory or intolerant to standard chemotherapies: Results of the primary analysis. Ann Oncol. 2019 Jul;30(Supplement 4):IV16. doi: 10.1093/annonc/mdz155.057
- Individual participant dataSharing planned: Yes. Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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CRC
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.
Vladimir MOISEENKO, Prof. principal investigator
Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)
2 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 S95005 in people with Metastatic Colorectal Cancer, run by Institut de Recherches Internationales Servier at 2 sites in Russia.
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 6 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 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?
Progression free survival (PFS) rate (time frame: at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274882, which also lists 1 linked publication.
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 25 Jul 2024.