Clinical trial NCT03274882: Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic
colorectal
cancer
Lonsurf
S95005
Russia
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2017-09-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression free survival (PFS) rate
timeFrame: at 2 months
Secondary outcomes:
measure: Progression-Free Survival (PFS).
timeFrame: Through study completion, an average of 12 weeks
measure: Overall Response Rate (ORR).
timeFrame: Through study completion, an average of 12 weeks
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, an average of 12 weeks
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in physical examination and performance status (ECOG) [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in blood pressure [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in heart rate [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in body temperature [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in respiration rate [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in body weight [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
measure: Abnormalities in 12-leads ECG parameters [safety and tolerability]
timeFrame: Through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)
Study officials:
affiliation: Saint Petersburg Clinical Scientific-Practical Center of Specialized Medical Care (Oncological)
name: Vladimir MOISEENKO, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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