Phase 2
Completed N=154
A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Source: ClinicalTrials.gov NCT02743221 ↗Enrolled (actual)
154
Serious AEs
56.2%
Results posted
Apr 2019
Primary outcomePrimary: Progression Free Survival (PFS) — 9.2; 7.8 months — p=0.09
Summary
The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
9.2; 7.8 | 0.09 |
| SECONDARY Overall Response Rate (ORR) |
26; 23 | 0.73 |
| SECONDARY Duration of Response (DR) |
7.9; 9.9 | — |
| SECONDARY Disease Control Rate (DCR) |
66; 59 | 0.22 |
| SECONDARY Overall Survival (OS) |
18.0; 16.2 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- Written informed consent obtained.
- Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
- Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- RAS status must have been determined (mutant or wild).
- Has at least one measurable metastatic lesion.
- No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
- Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
- Is able to take medication orally (i.e., no feeding tube).
- Has adequate organ function.
- Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
- Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
Exclusion Criteria
- Is a pregnant or lactating female.
- Has certain serious illness or serious medical condition(s) as described in the protocol.
- Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
- Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
- Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Has contra-indication to bevacizumab or capecitabine.
Data sourced from ClinicalTrials.gov (NCT02743221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.