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 (TASCO1)

Servier

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Capecitabine + bevacizumab; Drug: Trifluridine/tipiracil + bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02743221

CL2-95005-002

2015-004544-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

154 participants in 2 patient groups

Trifluridine/tipiracil + bevacizumab

Experimental group

Description:

Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.

Treatment:

Drug: Trifluridine/tipiracil + bevacizumab

Capecitabine + bevacizumab

Active Comparator group

Description:

Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks

Treatment:

Drug: Capecitabine + bevacizumab