Clinical Trials /

Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)

NCT03834220

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Solid Tumor

Interventions

DrugSynonymsArms
Debio 1347Debio 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

NameTypeDescriptionInterventions
Debio 1347ExperimentalParticipants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.
  • Debio 1347

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 (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:Not yet recruiting
Lead Sponsor:Debiopharm International SA

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