Trial record 1 of 1 for:
debio 1347-201
Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
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| ClinicalTrials.gov Identifier: NCT03834220 |
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Recruitment Status :
Terminated
(Due to lower antitumor activity than expected)
First Posted : February 7, 2019
Last Update Posted : April 4, 2022
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Sponsor:
Debiopharm International SA
Collaborators:
Caris Life Sciences
Optimal Research (Just In Time sites)
Information provided by (Responsible Party):
Debiopharm International SA
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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) |
| Actual Enrollment : | 63 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | March 22, 2019 |
| Actual Primary Completion Date : | December 31, 2020 |
| Actual Study Completion Date : | January 4, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Debio 1347
Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles.
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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 :
- Objective Response Rate (ORR) [ Time Frame: Up to 44 months ]
Secondary Outcome Measures :
- 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 ]
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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
Locations
Show 105 study locations
Sponsors and Collaborators
Debiopharm International SA
Caris Life Sciences
Optimal Research (Just In Time sites)
| Responsible Party: | Debiopharm International SA |
| ClinicalTrials.gov Identifier: | NCT03834220 |
| Other Study ID Numbers: |
Debio 1347-201 2018-003584-53 ( EudraCT Number ) |
| First Posted: | February 7, 2019 Key Record Dates |
| Last Update Posted: | April 4, 2022 |
| Last Verified: | March 2022 |
| 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 |
Additional relevant MeSH terms:
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Neoplasms |