Clinical trial · Interventional
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
NCT02202746CI-TRIAL-00045644terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision to end monotherapy development of the compound in breast cancer.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ER | — | UNRESOLVED | — |
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| HER2 | — | UNRESOLVED | — |
| HER2 Positive | — | UNRESOLVED | — |
| MBC | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Triple Negative | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lucitanib | Drug | Lucitanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: Lucitanib (CO-3810) 10 mg daily
- description
- 10 mg of lucitanib daily in patients with FGFR1-amplified or 11q-amplified metastatic breast cancer.
- interventionNames
- Drug: Lucitanib
- type
- EXPERIMENTAL
- label
- Cohort B: Lucitanib (CO-3810) 15 mg daily
- description
- 15 mg of lucitanib daily in patients with FGFR1-amplified and 11q-amplified metastatic breast cancer.
- interventionNames
- Drug: Lucitanib
- type
- EXPERIMENTAL
- label
- Cohort C: Lucitanib (CO-3810) 10 mg daily
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment * Prior treatment with standard first line therapy in the metastatic setting * Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q amplification status * Demonstrated progression of disease by radiological or clinical assessment (Measurable disease according to RECIST Version 1.1 is NOT required for enrollment) * Estimated life expectancy \>6 months Exclusion Criteria: * Current or recent treatment with biologic anticancer therapies * Ongoing AEs from prior anticancer therapies * Active central nervous system (CNS) metastases * Clinically significant or uncontrolled hypertension or cardiac disease * Females who are pregnant or breastfeeding
References
Publications (1)
- DERIVEDLiao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18. PMID 35844029