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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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).
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
Progression free survival (PFS) rate
percentage of patients alive without investigator-assessed radiological disease progression according to RECIST 1.1 after 2 months
Time frame: at 2 months
Progression-Free Survival (PFS).
based on Investigator review of the images according to RECIST 1.1
Time frame: Through study completion, an average of 12 weeks
Overall Response Rate (ORR).
based on Investigator review of the images according to RECIST 1.1
Time frame: Through study completion, an average of 12 weeks
Disease Control Rate (DCR)
based on Investigator review of the images according to RECIST 1.1
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
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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