Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834220
Recruitment Status : Terminated (Due to lower antitumor activity than expected)
First Posted : February 7, 2019
Last Update Posted : April 4, 2022
Sponsor:
Collaborators:
Caris Life Sciences
Optimal Research (Just In Time sites)
Information provided by (Responsible Party):
Debiopharm International SA

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 7, 2019
Last Update Posted Date April 4, 2022
Actual Study Start Date  ICMJE March 22, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
Objective Response Rate (ORR) [ Time Frame: Up to 44 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2020)
63
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
125
Actual Study Completion Date  ICMJE January 4, 2022
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03834220
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Debiopharm International SA
Study Sponsor  ICMJE Debiopharm International SA
Collaborators  ICMJE
  • Caris Life Sciences
  • Optimal Research (Just In Time sites)
Investigators  ICMJE Not Provided
PRS Account Debiopharm International SA
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP