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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005843-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Valerio Therapeutics | INDUSTRY |
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The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.
Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.
The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belinostat | Experimental | Belinostat 1000 mg/m^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belinostat | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Population Pharmacokinetics | 24 months |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Brown, MD | H:S Rigshospitalet, Department of Hematology, Denmark | Principal Investigator |
| Pier L Zinzani, MD | Università di Bologna, Italy | Principal Investigator |
| André Bosly, MD | Cliniques Universitaires UCL Mont Godinne, Belgium | Principal Investigator |
| Georges Fillet, MD | University of Liege, Belgium | Principal Investigator |
| Eric van den Neste, MD | Clinique Universitaier Saint Luc, Belgium | Principal Investigator |
| Nicolas Monier, MD | Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France | Principal Investigator |
| Elisabeth Perez, MD | Groupe Hospitalier Sud Réunion, France | Principal Investigator |
| Maria Delioukina, MD | City of Hope National Medical Center, USA | Principal Investigator |
| Adam Lerner, MD | Boston Medical Center, USA |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Wilshire Oncology Medical Group, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26921086 | Result | Campbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23. |
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Participants with relapsed or refractory T-Cell lymphoma who signed the informed consent form and met all Inclusion/Exclusion criteria were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belinostat | Belinostat 1000mg/m^2 administered as a 30 minute IV infusion from Days 1-5 of a 3-week cycle until disease progression or unmanageable treatment-related toxicities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Duration of Response | The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. | 24 months |
| Time to Progression | Time to progression was defined as the time (in months) from first administration of treatment to the date of disease progression based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. | 24 months |
| Progression Free Survival | Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. | 24 months |
| Overall Survival | Overall Survival was the time from first administration of study treatment until the date of death. | 24 months |
| Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) | A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities. | 24 months |
| Lydia Dreosti, MD | Pretoria Academic Hospital, South Africa | Principal Investigator |
| D. Moodley, MD | Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa | Principal Investigator |
| Hanneke C. Kluin-Nelemans, MD | University Medical Center Groningen UMCG, The Netherlands | Principal Investigator |
| G. Sissolak, MD | Tygerberg Hospital, Cape Town, South Africa | Principal Investigator |
| L. Verdonk, MD | Isala Clinics, Zwolle, The Netherlands | Principal Investigator |
| O. Visser, MD | VU Medical Center, Amsterdam, The Netherlands | Principal Investigator |
| Owen A. O'Connor, MD | New York University Cancer Institute, USA | Principal Investigator |
| Sarit Assouline, MD | McGill University, Department of Oncology Clinical Research Program, Montreal, Canada | Principal Investigator |
| Juan Manuel Sancho Cia, MD | ICO Hospital Germans Trias i Pujol, Badalona, Spain | Principal Investigator |
| Consolación Rayon, MD | Hospital Universitario Central de Asturias, Oviedo, Spain | Principal Investigator |
| Sonia Gonzales, MD | Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain | Principal Investigator |
| Lorenz Trümper, MD | Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany | Principal Investigator |
| Andreas Viardot, MD | Universitätsklinikum Ulm, Ulm, Germany | Principal Investigator |
| Georg Hess, MD | Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany | Principal Investigator |
| Hans-Heinrich Wolf, MD | Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany | Principal Investigator |
| Andreas Neubauer, MD | University Hospital Marburg, Marburg, Germany | Principal Investigator |
| Michele Frank, MD | Cascade Cancer Center | Principal Investigator |
| Madeleine Duvic, MD | UT - M. D. Anderson Cancer Center | Principal Investigator |
| Andrei Shustov, MD | Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance | Principal Investigator |
| Melissa Runge-Morris, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Nalini Janakiraman, MD | Henry Ford Health System | Principal Investigator |
| Amanda Cashen, MD | Wasington University School of Medicine- Division of Oncology | Principal Investigator |
| Beata Holkova, MD | Massey Cancer Center | Principal Investigator |
| Mohammad Tirgan, MD | Hematology Associates | Principal Investigator |
| Bernard Poiesz, MD | Upstate Medical Univeristy Syracuse | Principal Investigator |
| Charles Farber, MD | Morristown Memorial Hospital | Principal Investigator |
| Zale Bernstein, MD | Erie County Medical Center (Roswell Park) | Principal Investigator |
| Ralph Boccia, MD | Center for Cancers and Blood Disorders | Principal Investigator |
| David Grinblatt, MD | Kellogg Cancer Care Center | Principal Investigator |
| Laura Blakely, MD | Accelerated Community Oncology Reseaerch Network, Inc. (ACORN) | Principal Investigator |
| David Dennis, MD | Boca Raton Clinical Research Associates | Principal Investigator |
| Fernando Camacho, MD | Bronx River Medical Associates, PC | Principal Investigator |
| Eliot Epner, MD | Penn State Hershey Cancer Institute | Principal Investigator |
| La Verne |
| California |
| 91750 |
| United States |
| Comprehensive Cancer Center | Palm Springs | California | 92262 | United States |
| Yale Cancer Center-Section of Medical Oncology | New Haven | Connecticut | 06520 | United States |
| Oncology Associates of Bridgeport | Trumbull | Connecticut | 06611 | United States |
| Boca Raton Clinical Research Associates | Boca Raton | Florida | 33432 | United States |
| Georgia Health Sciences University | Augusta | Georgia | 30912-3125 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Kellogg Cancer Care Center | Evanston | Illinois | 60201 | United States |
| Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland | Niles | Illinois | 60714 | United States |
| Illinois CancerCare, P.C. | Peoria | Illinois | 61615 | United States |
| Center for Cancers and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Northern New Jersey Cancer Associates | Hackensack | New Jersey | 07601 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Erie County Medical Center (Roswell Park) | Buffalo | New York | 14215 | United States |
| Monter Cancer Center | Lake Success | New York | 11067 | United States |
| New York University Cancer Institute | New York | New York | 10016 | United States |
| New York University | New York | New York | 10016 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Upstate Medical Univeristy Syracuse | Syracuse | New York | 13210 | United States |
| Bronx River Medical Associates, PC | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Hematology Associates | Bedford | Ohio | 44146 | United States |
| St Luke's Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Penn State Hershey Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Avera Cancer Center | Sioux Falls | South Dakota | 57105 | United States |
| Associates In Oncology and Hematology | Chattanooga | Tennessee | 37421 | United States |
| University of Tennessee Cancer Institute | Knoxville | Tennessee | 37920 | United States |
| Accelerated Community Oncology Reseaerch Network, Inc. (ACORN) | Memphis | Tennessee | 38138 | United States |
| UT - M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| The UT Health Science Centre at San Antonio | San Antonio | Texas | 78229 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0035 | United States |
| Cascade Cancer Center | Kirkland | Washington | 98304 | United States |
| Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| AZ St. Jan | Bruges | 8000 | Belgium |
| Clinique Universitaire Saint Luc, Service Hématologie | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| University of Liege, Divisions of Hematology and Medical Oncology | Liège | 4000 | Belgium |
| Cliniques Universitaires UCL Mont Godinne, Service Hématologie | Yvoir | 5530 | Belgium |
| University of British Columbia | Vancouver | British Columbia | V5Z 4E6 | Canada |
| CHA Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J1Z4 | Canada |
| McGill University | Montreal | H2W1S6 | Canada |
| CHC Split Clinic of Internal Diseases | Split | 21000 | Croatia |
| CHC Zagreb Clinic of Internal Diseases | Zagreb | 10000 | Croatia |
| UH Dubrava Clinic of Internal Diseases | Zagreb | 10000 | Croatia |
| CHC Rijeka, Clinic of Internal Diseases | Zagreb | 1000 | Croatia |
| H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241 | Copenhagen | 2100 | Denmark |
| Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique | Nice | 6202 | France |
| Groupe Hospitalier Sud Réunion, Site Saint-Pierre | Saint-Pierre | 97448 | France |
| Klinik Essen Süd, Evangelisches Krankenhaus | Essen | 45239 | Germany |
| Leitender Oberarzt/Klinik für Onkologie und Hämatologie | Frankfurt | 60488 | Germany |
| Universität Göttingen, Abteilung Hämatologie und Onkologie | Göttingen | 37075 | Germany |
| Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg | Halle | 06120 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66424 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | 04103 | Germany |
| Universitätsmedizin der johannes Gutenberg -Universität Mainz | Mainz | 55131 | Germany |
| University Hospital Marburg | Marburg | 35043 | Germany |
| Münchner Studienzentrum Klinikum Rechts der Isar | München | 81675 | Germany |
| Klinikum Nuernberg Nord | Nuremberg | 90419 | Germany |
| Universitätsklinikum Rostock | Rostock | 18057 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Szt István és Szt. Laszlo | Budapest | 1097 | Hungary |
| Belgyógyászati Klinika | Debrecen | 4032 | Hungary |
| Belgyógyászati Klinika Györ | Győr | 9042 | Hungary |
| Belgyógyászati Klinika es Kardiologial Központ | Szeged | 6720 | Hungary |
| The Soroka University Medical Center | Beersheba | 84101 | Israel |
| Rambam Medical Center Department of Hematology | Haifa | 31096 | Israel |
| Hadassah University Hospital Sharet Building Department of Hematology | Jerusalem | 91120 | Israel |
| Rabin Medical Center Belinson Campus | Petah Tikva | 49100 | Israel |
| Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica | Bologna | 40138 | Italy |
| Ospedale Policlinico Careggi | Florence | 50134 | Italy |
| VU Medical Center, Department of Haematology | Amsterdam | 7081 HV | Netherlands |
| University Medical Center Groningen UMCG, Department of Haematologie | Groningen | 9700 | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3015 | Netherlands |
| Isala Clinics, Department of Haematololgy | Zwolle | 8025 AB | Netherlands |
| Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii | Gdansk | 80-952 | Poland |
| Małopolskie Centrum Medyczne | Krakow | 30-510 | Poland |
| Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii | Lodz | 93-510 | Poland |
| Szpital Wojewódzki w Opolu/Oddział Hematologii | Opole | 45-051 | Poland |
| MTZ Clinical Research Sp z o.o. | Warsaw | 02-106 | Poland |
| Instytut Hematologii i Transfuzjologii Klinika Hematologii | Warsaw | 02-776 | Poland |
| Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala | Warsaw | 04-141 | Poland |
| State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | 454087 | Russia |
| Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences | Moscow | 115478 | Russia |
| Research Center of Haematology | Moscow | 125167 | Russia |
| Narodny Onkologicky Ustav (NOU) | Bratislava | 83310 | Slovakia |
| Klinika Hematologie a Onkohematologie FNLP a LF UPJS | Košice | 04066 | Slovakia |
| Tygerberg Hospital, Department of Radiation Oncology | Bellville | 7505 | South Africa |
| Drs pirjol, Szpak and Moodley Inc. | Durban | 4126 | South Africa |
| Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital | Pretoria | 0002 | South Africa |
| Pretoria Academic Hospital, Department of Radiation Oncology | Pretoria | 0002 | South Africa |
| Complexo Hospitalario a Coruna | A Coruña | 15006 | Spain |
| Hospital Clinico Universitario de Santiago | A Coruña | 15706 | Spain |
| ICO Hospital Germans Trias i Pujol | Badalona | 08918 | Spain |
| Hospital Duran i Reinals | Barcelona | 08007 | Spain |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | 30120 | Spain |
| Hospital General Universitario Gregorio Maranón | Madrid | CP 28007 | Spain |
| Hospital Universitario Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33006 | Spain |
| St James's Institute of Oncology Bexley Wing | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry | London | EC1A 7BE | United Kingdom |
| The Christie NHS Foundation Trust, The Christie Hospital, | Manchester | M20 4BX | United Kingdom |
| Northern Centre for Cancer Care, Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| The Royal Marsden Haemato-Oncology Wards | Sutton | SM2 5PT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Full Analysis Set included all participants who were received at least 1 dose of belinostat.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Belinostat | Belinostat 1000 mg/m^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response. | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed peripheral T-cell lymphoma (PTCL) diagnosis. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Time to Response | Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analyzed included responding participants (CR/PR) only. | Posted | Median | Full Range | weeks | 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response | The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analysed included responding participants (CR/PR) only. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Progression | Time to progression was defined as the time (in months) from first administration of treatment to the date of disease progression based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir. | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival was the time from first administration of study treatment until the date of death. | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) | A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities. | Full Analysis Dataset included all participants who received at least 1 dose of belinostat. | Posted | Count of Participants | Participants | 24 months |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Population Pharmacokinetics | Not Posted | 24 months | Participants |
Up to 25 months
Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
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 | Belinostat | Belinostat 1000 mg/m^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities. | 22 | 129 | 61 | 129 | 125 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Multi-organ disorder | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal fungal infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Impaired self-care | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Toxic cataract | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchopneumopathy | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Edema Peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Infusion Site Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gajanan Bhat, PhD | Spectrum Pharmaceuticals | 949-743-9219 | Gajanan.Bhat@sppirx.com |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C487081 | belinostat |
Not provided
Not provided
Not provided
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