Description:
The primary objective of this study is to assess the efficacy of Debio 1347 in terms of
objective response rate (ORR) in participants with solid tumors harboring fibroblast growth
factor receptor (FGFR)1-3 gene fusion/rearrangement.
Title
- Brief Title: Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
- Official Title: A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3
Clinical Trial IDs
- ORG STUDY ID:
Debio 1347-201
- SECONDARY ID:
2018-003584-53
- NCT ID:
NCT03834220
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Debio 1347 | | Debio 1347 |
Purpose
The primary objective of this study is to assess the efficacy of Debio 1347 in terms of
objective response rate (ORR) in participants with solid tumors harboring fibroblast growth
factor receptor (FGFR)1-3 gene fusion/rearrangement.
Trial Arms
Name | Type | Description | Interventions |
---|
Debio 1347 | Experimental | Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles. | |
Eligibility Criteria
Inclusion Criteria:
- Cytologically or histologically confirmed advanced solid tumor
- Radiographic progression on prior systemic therapy; prior localized therapy (i.e.,
radiation, ablation, embolization) is allowed provided radiographic progression
out-of-field or in the treatment, field is shown
- Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene
fusion/rearrangement potentially leading to a functional FGFR aberrant protein,
identified through local and/or central molecular assay
Exclusion Criteria:
- History of hypersensitivity to any of the excipients in the Debio 1347 formulation
- History and/or current evidence of ectopic mineralization/calcification, including but
not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon
calcifications
- Administration of any investigational agent within 2 weeks prior to initial dosing
with Debio 1347 (3 weeks for immune checkpoint inhibitors)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months) |
Safety Issue: | |
Description: | |
Measure: | Disease Control Rate (DCR) |
Time Frame: | Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months) |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months) |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | |
Measure: | Trough Concentration (Ctrough) of Debio 1347 |
Time Frame: | Up to Cycle 2 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Measure: | Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCt) of Debio 1347 |
Time Frame: | Up to Cycle 2 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Measure: | Correlation of Debio 1347 plasma concentration and QTcF |
Time Frame: | Up to 44 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Debiopharm International SA |
Last Updated
August 26, 2021