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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274882
• Other study ID #: CL2-95005-003
• Secondary ID: ISRCTN14228310
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2017
• Est. completion date: December 3, 2018

Study information

• Verified date: May 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 3, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Russian Federation	Russian Cancer Research Center n.a. NN Blokhin (RCRC), Clinical Pharmacology and Chemotherapy department	Moscow
Russian Federation	Saint Petersburg Clinical Scientific-Practical Center of Special Medical Care (Oncology Center)	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) rate	percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months	at 2 months
Secondary	Progression-Free Survival (PFS).	based on Investigator review of the images according to RECIST 1.1	Through study completion, an average of 12 weeks
Secondary	Overall Response Rate (ORR).	based on Investigator review of the images according to RECIST 1.1	Through study completion, an average of 12 weeks
Secondary	Disease Control Rate (DCR)	based on Investigator review of the images according to RECIST 1.1	Through study completion, an average of 12 weeks
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in physical examination and performance status (ECOG) [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in blood pressure [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in heart rate [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in body temperature [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in respiration rate [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in body weight [safety and tolerability]		Through study completion, an average of 12 weeks
Secondary	Abnormalities in 12-leads ECG parameters [safety and tolerability]		Through study completion, an average of 12 weeks

External Links

•   Lay Summary
•   Results Summary