Metastatic Colorectal Cancer
Conditions
Keywords
metastatic, colorectal, cancer, Lonsurf, S95005, Russia
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.
Interventions
DRUGS95005
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).
Sponsors
ADIR, a Servier Group company
Institut de Recherches Internationales Servier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR). | Through study completion, an average of 12 weeks | based on Investigator review of the images according to RECIST 1.1 |
| Disease Control Rate (DCR) | Through study completion, an average of 12 weeks | based on Investigator review of the images according to RECIST 1.1 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis) [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in physical examination and performance status (ECOG) [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Progression-Free Survival (PFS). | Through study completion, an average of 12 weeks | based on Investigator review of the images according to RECIST 1.1 |
| Abnormalities in heart rate [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in body temperature [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in respiration rate [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in body weight [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in 12-leads ECG parameters [safety and tolerability] | Through study completion, an average of 12 weeks | — |
| Abnormalities in blood pressure [safety and tolerability] | Through study completion, an average of 12 weeks | — |
Countries
Russia
Outcome results
None listed