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

• ClinicalTrials.gov Identifier: NCT03834220
• Recruitment Status: Terminated
• First Posted: February 7, 2019
• Last Update Posted: April 4, 2022
• Sponsor: Debiopharm International SA
• Collaborators: Caris Life Sciences; Optimal Research (Just In Time sites)
• Information provided by (Responsible Party): Debiopharm International SA

Tracking Information

• First Submitted Date: February 4, 2019
• First Posted Date: February 7, 2019
• Last Update Posted Date: April 4, 2022
• Actual Study Start Date: March 22, 2019
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 6, 2019): Objective Response Rate (ORR) [ Time Frame: Up to 44 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 30, 2020)

• 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) ]
• 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) ]
• 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) ]
• Overall Survival (OS) [ Time Frame: Up to 44 months ]
• Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 44 months ]
• Trough Concentration (Ctrough) of Debio 1347 [ Time Frame: Up to Cycle 2 (each cycle is 28 days) ]
• 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) ]
• Correlation of Debio 1347 plasma concentration and QTcF [ Time Frame: Up to 44 months ]

Original Secondary Outcome Measures (submitted: February 6, 2019)

• 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) ]
• 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) ]
• 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) ]
• Overall Survival (OS) [ Time Frame: Up to 44 months ]
• Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 44 months ]
• Trough Concentration (Ctrough) of Debio 1347 [ Time Frame: Up to Cycle 2 (each cycle is 28 days) ]
• 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) ]
• Correlation of Debio 1347 plasma concentration and QTcF [ Time Frame: Up to 44 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor

Intervention

Drug: Debio 1347

80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.

Study Arms

Experimental: Debio 1347

Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.

Intervention: Drug: Debio 1347

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 31, 2020): 63
• Original Estimated Enrollment (submitted: February 6, 2019): 125
• Actual Study Completion Date: January 4, 2022
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Brazil, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Greece, Korea, Republic of, Netherlands, Norway, Philippines, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Ukraine, United Kingdom, United States

Administrative Information

• NCT Number: NCT03834220
• Other Study ID Numbers: Debio 1347-201; 2018-003584-53 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Debiopharm International SA
• Study Sponsor: Debiopharm International SA

Collaborators

• Caris Life Sciences
• Optimal Research (Just In Time sites)

• Investigators: Not Provided
• PRS Account: Debiopharm International SA
• Verification Date: March 2022