Study of efficacy and safety of S 95005 (TAS-102) in patients with metastatic colorectal cancer who failed standard chemotherapies
| ISRCTN | ISRCTN14228310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14228310 |
| ClinicalTrials.gov (NCT) | NCT03274882 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CL2-95005-003 |
| Sponsor | Institut de Recherche Internationales Servier (IRIS) |
| Funder | ADIR |
- Submission date
- 22/09/2016
- Registration date
- 02/11/2016
- Last edited
- 02/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at the time of registration and not expected to be provided in the future.
Contact information
Scientific
Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Chemotherapy Department
68 A, Lit A
Ulitsa Leningradskaya
Poselok Pesochny
Saint Petersburg
197758
Russian Federation
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre open-label single-arm study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific 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 |
| Study objectives | To evaluate the efficacy and the safety of S 95005 in patients with metastatic colorectal cancer who are refractory or intolerant to standard chemotherapies |
| Ethics approval(s) | Ethical Counsil at Ministry of Healthcare of Russian Federation, 09/08/2016, ref: 4017917-20-1 |
| Health condition(s) or problem(s) studied | Metastatic colorectal cancer |
| Intervention | Single arm study where film-coated tablets of S95005 containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, are given orally twice daily at the dose of 35 mg/m2/dose. The treatment is given 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), patients will be followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Trifluridine + tipiracil hydrochloride (S 95005/TAS-102) |
| Primary outcome measure(s) |
Progression free survival (PFS) rate at 2 months (percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months). |
| Key secondary outcome measure(s) |
1. Antitumor activity (Progression-Free Survival, Overall Response Rate, Disease Control Rate) based on Investigator review of the images according to RECIST 1.1, within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter. |
| Completion date | 03/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 26 |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. Male or female aged ≥18 years of age 2. Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum 3. 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 4. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1 5. Has at least one measurable metastatic lesion(s) 6. Has adequate organ function 7.Women of childbearing potential must have been tested negative in a serum pregnancy test within 3 days prior to inclusion 8. 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 |
| Key exclusion criteria | 1. Pregnancy, breastfeeding 2, Has previously received S 95005 or history of allergic reaction attributed to compounds of similar composition to S 95005 3. Has certain serious illnesses or medical conditions 4. Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion 5. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anaemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity) |
| Date of first enrolment | 23/01/2017 |
| Date of final enrolment | 23/07/2017 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
115478
Russian Federation
197758
Russian Federation
115478
Russian Federation
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ after the Marketing Authorisation has been granted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2019 | 02/01/2020 | Yes | No |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
02/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
17/12/2019: The following changes have been made:
1. The sponsor website has been updated.
2. The NCT code has been added.
3. The sponsor organisation name has been changed from "Institut de Recherche Internationales Servier" to "Institut de Recherche Internationales Servier (IRIS)".
4. The basic results summary link has been added.
5. The plain English results link has been added.
6. The drug name has been added.
20/12/2018: The overall trial end date has been changed from 31/12/2018 to 03/12/2018.
20/08/2019: Overall trial end date changed from 28/09/2018 to 31/12/2018.
10/04/2018: Publication and dissemination plan and IPD sharing statement updated, overall trial end date changed from 08/12/2017 to 28/09/2018.
20/03/2017: Ethics approval information added.
