Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies

NCT ID: NCT03274882

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2018-12-03

Brief 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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S95005

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.

Group Type: EXPERIMENTAL

S95005

Intervention Type: DRUG

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).

Interventions

S95005

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).

Intervention Type: DRUG

Other Intervention Names

TAS-102

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR, a Servier Group company

INDUSTRY

Sponsor Role: collaborator

Institut de Recherches Internationales Servier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir MOISEENKO, Prof.

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)

Locations

Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department

Moscow, , Russia

Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)

Saint Petersburg, , Russia

Countries

Russia

References

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

Reference Type: BACKGROUND

Study Documents

Document Type: Individual Participant Data Set

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Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

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Document Type: Clinical Study Report

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Document Type: Study-level clinical trial data

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Other Identifiers

ISRCTN14228310

Identifier Type: REGISTRY

Identifier Source: secondary_id

CL2-95005-003

Identifier Type: -

Identifier Source: org_study_id