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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003584-53 | EudraCT Number |
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Due to lower antitumor activity than expected
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| Name | Class |
|---|---|
| Caris Life Sciences | INDUSTRY |
| Optimal Research (Just In Time sites) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Debio 1347 (Biliary Tract Cancer) | Experimental | Participants with biliary tract cancer were included in this cohort to receive Debio 1347 80 milligrams (mg) tablets, orally, once daily (QD), from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 20 weeks). |
|
| Cohort 2: Debio 1347 (Urothelial Cancer) | Experimental | Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks). |
|
| Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Experimental | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debio 1347 | Drug | Debio 1347 oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria | ORR was defined as the percentage of participants with a best overall response (BOR) of partial or complete response (PR or CR). BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Up to disease progression or end of study (up to 1 year and 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC) | DOR was defined as the time from the date of the initial PR or CR to date of the first documented progression or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers - Scottsdale | Scottsdale | Arizona | 85260 | United States | ||
| University of Arizona Cancer Center |
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A total of 63 participants with solid tumors harboring FGFR1-3 gene fusion/rearrangement were enrolled into one of the 3 cohorts: Cohort 1: Biliary Tract Cancer (N=30), Cohort 2: Urothelial Cancer (N=4), Cohort 3: All Other Solid Tumor Histologies (N=29) to receive Debio 1347.
A total of 63 participants were enrolled at 31 investigational sites in the United States, France, Spain, Finland, Korea, Singapore, Australia, Bulgaria, Denmark, Norway, Russian Federation, Taiwan, and the United Kingdom from 22 March 2019 to 04 January 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Debio 1347 (Biliary Tract Cancer) | Participants with biliary tract cancer were included in this cohort to receive Debio 1347 80 milligrams (mg) tablets, orally, once daily (QD), from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 20 weeks). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2020 | Nov 29, 2023 |
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| Up to disease progression or end of study (up to 2 years and 9 months) |
| Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC) | DCR was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or stable disease (SD) ≥6 weeks. BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | Up to disease progression or end of study (up to 2 years and 9 months) |
| Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC) | PFS was defined as the time from the start date of treatment to date of the first documented progression or death due to any cause. | From the start of the study up to disease progression or death (up to 2 years and 9 months) |
| Overall Survival (OS) | OS was defined as the time from the start date of treatment to date of death due to any cause. Participants with no documented death were censored at the last date known to be alive. | Until death or loss to follow-up or end of study (up to 2 years and 9 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by National Cancer Institute Common Terminology Criteria (NCI CTCAE) v5.0 and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that either starts or worsens in severity on or after the first administration of the study drug and within 30 days of the last administration of the study drug. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months) |
| Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in Plasma | Geometric mean and geometric percent CV summary was estimated based on log-linear model. | Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days) |
| Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in Plasma | Geometric mean and geometric percent CV summary was estimated based on log-linear model. | Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days) |
| Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | Pre-dose on Days 14 and 28, and 1, 3, 7 hours post-dose on Day 28 of Cycle 1; pre-dose on Days 14 and 28, and 3 hours post-dose on Day 28 of Cycle 2 (each cycle length = 28 days) |
| Tucson |
| Arizona |
| 85721 |
| United States |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | United States |
| University of California San Francisco | San Francisco | California | 94115 | United States |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
| H. Lee Moffitt Cancer Center and Research Institute, Inc | Tampa | Florida | 33612 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 10202 | United States |
| Tulane University Cancer Center | New Orleans | Louisiana | 70122 | United States |
| The John Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Memorial Sloan Kettering Cancer Center | Middletown | New Jersey | 07748 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Memorial Sloan Kettering Cancer Center | Harrison | New York | 10604 | United States |
| Memorial Sloan-Kettering Hospital | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| UC Health, LLC. | Cincinnati | Ohio | 45229 | United States |
| The Ohio State University Wexner Medical Center - James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| CTCA Cancer Treatment Centers | Tulsa | Oklahoma | 74133 | United States |
| West Penn - Allegheny Oncology Network | Pittsburgh | Pennsylvania | 15224 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah Hospitals & Clinics | Salt Lake City | Utah | 84108 | United States |
| Fred Hutchinson/Seattle Care Alliance | Seattle | Washington | 98109 | United States |
| University of Wisconsin | Madison | Wisconsin | 53706 | United States |
| Southern Highlands Private Hospital | Bowral | NSW 2576 | Australia |
| Peninsula and Southeast Oncology (PASO) | Frankston | 3199 | Australia |
| Linear Clinical Research, B Block Sir Charles Gairdner Hospital | Nedlands | 6009 | Australia |
| John Flynn Private Hospital | Tugun | 4224 | Australia |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria |
| Landesklinikum Wiener Neustadt | Wiener Neustadt | 2700 | Austria |
| Hospital de Caridade de Ijuí, Avenida David J Martins | Ijuí | 98700-000 | Brazil |
| Hospital de Clínicas de Porto Alegre | Rio Grande | 90035-903 | Brazil |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Santo André | 09060-870 | Brazil |
| ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo | São Paulo | 01246-000 | Brazil |
| MHAT - Dobrich | Dobrich | 9300 | Bulgaria |
| Complex Oncological Center - Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| MHAT "Serdika", EOOD | Sofia | 1632 | Bulgaria |
| General Hospital Varazdin | Varaždin | 42000 | Croatia |
| University Hospital Centre, Sestre Milosrdnice | Zagreb | 10000 | Croatia |
| Fakultni nemocnice u sv. Anny v Brne | Brno | 656 91 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 50005 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Thomayerova nemocnice | Prague | 14000 | Czechia |
| Ålborg Universitets Hospital | Aalborg | 9100 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Docrates Syöpäsairaala | Helsinki | 00180 | Finland |
| Helsinki University Hospital | Helsinki | 00290 | Finland |
| ICO - Site Paul Papin | Angers | 49055 | France |
| CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque | Bordeaux | 33075 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Groupe Hospitalier Sud - Hôpital Haut Lévêque | Pessac | 33604 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| General Hospital of Athens Laiko | Athens | 11527 | Greece |
| General Hospital of Athens of Chest Diseases "SOTIRIA" | Athens | 11527 | Greece |
| General Hospital of Athens "Alexandra" | Athens | 11528 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Haga Ziekenhuis | The Hague | 2545 AA | Netherlands |
| Akershus University Hospital | Lørenskog | 1478 | Norway |
| Radiumhospitalet, Montebello | Oslo | 0310 | Norway |
| Cebu Doctors' University Hospital (CDUH), Research Office | Cebu City | 6000 | Philippines |
| Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory | Ermita | 1000 | Philippines |
| St. Luke's Medical Center, Human Cancer Biobank Research Center | Quezon City | 1112 | Philippines |
| Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu | Poznan | 60-355 | Poland |
| MTZ Clinical Research | Warsaw | 02-106 | Poland |
| Centrum Onkologii-Instytut im.M.Sklodowskiej Curie | Warsaw | 02-781 | Poland |
| S.C Delta Health Care S.R.L | Bucharest | 014142 | Romania |
| S.C Medisprof S.R.L. | Cluj-Napoca | 400641 | Romania |
| S.C Centrul de Oncologie Sf. Nectarie S.R.L. | Craiova | 200347 | Romania |
| S.C Oncocenter Oncologie Clinica S.R.L. | Timișoara | 300166 | Romania |
| SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" | Arkhangelsk | 163045 | Russia |
| TSBHI "Altai Territorial oncological dispensary" | Barnaul | 656049 | Russia |
| LLC Evimed | Chelyabinsk | 454048 | Russia |
| FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | 115478 | Russia |
| BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | 644013 | Russia |
| Tomsk Research Instutite of Oncology | Tomsk | 634028 | Russia |
| Singapore National Cancer Center (SNCC) | Singapore | 169610 | Singapore |
| Tan Tock Seng Hospital, Communicable Disease Centre | Singapore | 308440 | Singapore |
| Seoul National University Bundang Hospital, Department of Oncology Medical office | Gyeonggi-do | 13605 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital | Incheon | 21565 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital (SNUH) | Seoul | 03080 | South Korea |
| Ajou University Hospital, CRC room, Clinical Trial Center | Suwon | 16499 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Taichung Veterans General Hospital, The Radiation Oncology Department | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Medical University Hospital (TMUH) | Taipei | 11031 | Taiwan |
| Taipei Veterans General Hospital, Medical Science & Technology Building | Taipei | 11217 | Taiwan |
| Linkou Chang-Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipro | 49102 | Ukraine |
| SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery | Kharkiv | 61018 | Ukraine |
| Communal Non-profit Enterprise Regional Center of Oncology | Kharkiv | 61070 | Ukraine |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Guy's Hospital | London | SE1 9RY | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| The Christie | Manchester | M20 4BX | United Kingdom |
| Cohort 2: Debio 1347 (Urothelial Cancer) |
Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks) |
| FG002 | Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) Population consisted of all participants who received study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Debio 1347 (Biliary Tract Cancer) | Participants with biliary tract cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 20 weeks). |
| BG001 | Cohort 2: Debio 1347 (Urothelial Cancer) | Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks). |
| BG002 | Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Centrally Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria | ORR was defined as the percentage of participants with a best overall response (BOR) of partial or complete response (PR or CR). BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT Population consisted of all participants who received study drug. Overall number of participants analyzed is the number of participants with measurable disease and tumor assessment at Baseline. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to disease progression or end of study (up to 1 year and 9 months) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Centrally Measured by Independent Review Committee (IRC) | DOR was defined as the time from the date of the initial PR or CR to date of the first documented progression or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT Population consisted of all participants who received study drug. Only participants with best overall response of CR or PR were analyzed for this endpoint. | Posted | Median | 95% Confidence Interval | months | Up to disease progression or end of study (up to 2 years and 9 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as Centrally Measured by Independent Review Committee (IRC) | DCR was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or stable disease (SD) ≥6 weeks. BOR was defined as the best confirmed response observed from first administration of study drug until disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. | ITT population consisted of all participants who received study drug. Percentages are rounded off to the nearest single decimal point. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to disease progression or end of study (up to 2 years and 9 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as Centrally Measured by Independent Review Committee (IRC) | PFS was defined as the time from the start date of treatment to date of the first documented progression or death due to any cause. | ITT population consisted of all participants who received study drug. | Posted | Median | 95% Confidence Interval | months | From the start of the study up to disease progression or death (up to 2 years and 9 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the start date of treatment to date of death due to any cause. Participants with no documented death were censored at the last date known to be alive. | ITT population consisted of all participants who received study drug. | Posted | Median | 95% Confidence Interval | months | Until death or loss to follow-up or end of study (up to 2 years and 9 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Assessed by National Cancer Institute Common Terminology Criteria (NCI CTCAE) v5.0 and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that either starts or worsens in severity on or after the first administration of the study drug and within 30 days of the last administration of the study drug. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety Population consisted of all participants who received study drug. | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days post last dose (Up to 2 years and 9 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Trough Concentration at Steady State (Ctrough,ss) of Debio 1347 in Plasma | Geometric mean and geometric percent CV summary was estimated based on log-linear model. | Pharmacokinetic (PK) Population included participants who received one or more doses of Debio 1347 and have at least one PK concentration result available. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millilitre (ng/mL) | Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Debio 1347 in Plasma | Geometric mean and geometric percent CV summary was estimated based on log-linear model. | PK Population included participants who received one or more doses of Debio 1347 and have at least one PK concentration result available. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram (h*ng)/mL | Predose and post dose up to Cycle 2 Day 28 (each cycle length = 28 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | Correlation of Debio 1347 Plasma Concentration (C) and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | The study was terminated by sponsor and thus the analysis for this outcome measure was not deemed necessary and no data was collected. | Posted | Pre-dose on Days 14 and 28, and 1, 3, 7 hours post-dose on Day 28 of Cycle 1; pre-dose on Days 14 and 28, and 3 hours post-dose on Day 28 of Cycle 2 (each cycle length = 28 days) |
|
From first dose of study drug up to 30 days post last dose (up to 2 years and 9 months)
Safety Population consisted of all participants who received study drug. The all-cause mortality is reported for all participants enrolled in the study and who completed the study visits.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Debio 1347 (Biliary Tract Cancer) | Participants with biliary tract cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 20 weeks). | 9 | 30 | 14 | 30 | 30 | 30 |
| EG001 | Cohort 2: Debio 1347 (Urothelial Cancer) | Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks) | 1 | 4 | 2 | 4 | 4 | 4 |
| EG002 | Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). | 17 | 29 | 7 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data.
Due to the premature termination of participant recruitment and shortened follow-up, the primary efficacy analysis was likely underpowered in the final analysis, leading to greater statistical uncertainty in results.
Any publication or scientific communication related to this study can only take place once the agreement between the Sponsor and the Investigator has been reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Clinical Research & Development | Debiopharm International S.A. | 4121 321 01 11 | info-international@debiopharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2021 | Nov 29, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000602562 | CH5183284 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Not Willing to Provide |
|
| Other |
|
| OG002 | Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
|
|
Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks). |
| OG002 | Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
|
|
|
|
|
|
Participants with urothelial cancer were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 5.86 weeks).
| OG002 | Cohort 3: Debio 1347 (All Other Solid Tumor Histologies) | Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
|
|
Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
|
|
Participants with all other solid tumor histologies were included in this cohort to receive Debio 1347 80 mg tablets, orally, QD, from Day 1 to Day 28 in 28-day cycles until the occurrence of disease progression or unacceptable toxicity (up to a median duration of 8.14 weeks). |
|
|
|