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

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ClinicalTrials.gov Identifier: NCT03834220
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Debio 1347 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 11, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Debio 1347
Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.
Drug: Debio 1347
80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 44 months ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Overall Survival (OS) [ Time Frame: Up to 44 months ]
  5. Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 44 months ]
  6. Trough Concentration (Ctrough) of Debio 1347 [ Time Frame: Up to Cycle 2 (each cycle is 28 days) ]
  7. 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) ]
  8. Correlation of Debio 1347 plasma concentration and QTcF [ Time Frame: Up to 44 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834220


Contacts
Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
United States, Arizona
University of Arizona Cancer Center Not yet recruiting
Tucson, Arizona, United States, 85721
United States, California
Moores UCSD Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94115
United States, Florida
H. Lee Moffitt Cancer center Not yet recruiting
Tampa, Florida, United States, 33612
United States, Louisiana
Tulane University Cancer Center Not yet recruiting
New Orleans, Louisiana, United States, 70122
United States, Maryland
The John Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, New Jersey
Rutgers Cancer Institute of New Jersey Not yet recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Memorial Sloan-Kettering Hospital Not yet recruiting
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson/Seattle Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
Debiopharm International SA

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT03834220     History of Changes
Other Study ID Numbers: Debio 1347-201
2018-003584-53 ( EudraCT Number )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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