Study of efficacy and safety of S 95005 (TAS-102) in patients with metastatic colorectal cancer who failed standard chemotherapies
- Conditions
- Metastatic colorectal cancerCancerColorectal cancer
- Registration Number
- ISRCTN14228310
- Brief Summary
2019 results in https://doi.org/10.1093/annonc/mdz155.057 (added 02/01/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
1. Male or female aged =18 years of age
2. Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
3. 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
4. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
5. Has at least one measurable metastatic lesion(s)
6. Has adequate organ function
7.Women of childbearing potential must have been tested negative in a serum pregnancy test within 3 days prior to inclusion
8. 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
1. Pregnancy, breastfeeding
2, Has previously received S 95005 or history of allergic reaction attributed to compounds of similar composition to S 95005
3. Has certain serious illnesses or medical conditions
4. Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
5. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anaemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 1. Antitumor activity (Progression-Free Survival, Overall Response Rate, Disease Control Rate) based on Investigator review of the images according to RECIST 1.1, within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter.<br> 2. Safety and tolerability, at each visit, from the informed consent signature to the withdrawal visit , assessed by:<br> 2.1. Incidence of Adverse Events<br> 2.2. Laboratory tests: haematology, blood biochemistry and urinalysis<br> 2.3. Physical examination and performance status (ECOG)<br> 2.4. Vital signs: blood pressure, heart rate, body temperature, respiration rate, body weight<br> 2.5. 12-leads ECG parameters (only at baseline and at withdrawal visit)<br>