Study Stopped
Sponsor decided to discontinue the study during the Lead-In part and the Phase III part was not started due to strategic reasons.
Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
COLSTAR
A Randomised, Open-label, Multi-centre, Two-arm Phase 3 Study Comparing Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil to Trifluridine/Tipiracil Single Agent With a Safety Lead-In Part in Participants With KRAS/NRAS and BRAF Wild Type Metastatic Colorectal Cancer Previously Treated With Standard Treatment and Anti-EGFR Therapy
2 other identifiers
interventional
7
6 countries
15
Brief Summary
This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2022
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2023
CompletedResults Posted
Study results publicly available
March 5, 2024
CompletedAugust 20, 2024
July 1, 2024
1.2 years
January 25, 2022
January 16, 2024
July 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Dose-limiting Toxicities (DLTs) (Safety Lead-In Part)
DLTs observed during a 28-day period. A DLT is defined as the following: A clinically significant AE graded according to the NCI-CTCAE version 5.0, observed during the initial 28- day treatment period following the first IMP administration. Assessed as unrelated to underlying disease, disease progression, intercurrent illness, or concomitant medications. At least possibly related to the IMPs (futuximab/modotuximab or trifluridine/tipiracil or both) by the investigator and meeting criteria as outlined in the protocol.
End of cycle 1 (Each cycle is up to 28 days)
Overall Survival (OS) (In Double Negative, KRAS/NRAS and BRAF Wild Type Patients) (Phase III Part)
Time elapsed from date of randomization until the date of death from any cause
up to 4 years 9 months
Secondary Outcomes (4)
Overall Survival (Safety Lead-In Part)
up to 24 months
Overall Survival (In Triple Negative) (Phase III Part)
up to 4 years 9 months
Progression Free Survival (Phase III Part)
up to 4 years 9 months
Adverse Events (Phase III Part)
Through study completion, up to 4 years 9 months
Study Arms (2)
Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)
EXPERIMENTALTrifluridine/tipiracil (Phase III part)
ACTIVE COMPARATORInterventions
Concentrate for solution for infusion, futuximab/modotuximab will be administered via IV route, once weekly of each cycle at 9 mg/kg/dose at Cycle 1 Day 1 and then at 6 mg/kg/dose. Each cycle is up to 28 days.
Film-coated tablets of trifluridine/tipiracil (35 mg/m²/dose) will be administered orally before futuximab/ modotuximab administration, twice a day (BID) within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 14 days, followed by a 14-day rest. This treatment cycle will be repeated every 28 days.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis
- Participants with measurable or non-measurable lesion
- Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen
- Participants should have received previous treatment with commercially available anti-EGFR mAbs for ≥ 4 months
- Estimated life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate haematological, renal and hepatic function
You may not qualify if:
- Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman
- Participants with serious/active/uncontrolled infection
- Known clinically significant cardiovascular disease or condition
- Significant gastrointestinal abnormality
- Patients with other malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Michigan Oncology Clinic | Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Cleveland Clinic Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195, United States
UZA Edegem
Edegem, 2650, Belgium
UZ Leuven Campus Gasthuisberg
Leuven, 3000, Belgium
CHUUCL Namur site Godinne
Yvoir, 5530, Belgium
Rigshospitalet
Copenhagen, 2100, Denmark
Herning Regional Hospital (Regionhospitalet Godstrup)
Herning, 7400, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Docrates cancer center
Helsinki, 00180, Finland
TAYS (Tampere University Hospital)
Tampere, 33520, Finland
Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
Budapest, 1062, Hungary
Debreceni Egyetem, Klinikai Központ Onkológiai Klinika
Debrecen, 4032, Hungary
Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudomáyi Kar Oktatókórháza
Kecskemét, 6000, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Onkoterápiás Klinika
Szeged, 6720, Hungary
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Related Publications (1)
Ciardiello F, Yoshino T, Modest DP, Martin Fernandez L, Roby L, Fougeray R, Lockhart BP, Tabernero J. 436TiP COLSTAR: Randomized, open-label, multicentre, phase III study comparing futuximab/modotuximab plus trifluridine/tipiracil to trifluridine/tipiracil in KRAS/NRAS and BRAF wild type (wt) metastatic colorectal cancer (mCRC) previously treated with both standard and anti-EGFR treatment. Ann Oncol. 2022 Sep;33(Supplement 7):S733-S73. doi: 10.1016/j.annonc.2022.07.574
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Studies Department
- Organization
- Institut de Recherches Internationales Servier (I.R.I.S.)
Study Officials
- PRINCIPAL INVESTIGATOR
Fortunato Ciardiello
University of Campania Luigi Vanvitelli
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2022
First Posted
February 4, 2022
Study Start
April 21, 2022
Primary Completion
June 21, 2023
Study Completion
June 21, 2023
Last Updated
August 20, 2024
Results First Posted
March 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.