Bladder Cancer Clinical Trial
— ATLASOfficial title:
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Verified date | June 2023 |
Source | zr Pharma & GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Status | Terminated |
Enrollment | 97 |
Est. completion date | January 15, 2020 |
Est. primary completion date | December 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra) - Received 1 or 2 prior treatment regimens for advanced or metastatic disease - Confirmed radiologic disease progression during or following recent treatment - Mandatory biopsy is required during screening - Measurable disease per RECIST v1.1 - Adequate organ function - ECOG 0 or 1 Exclusion Criteria: - Prior treatment with a PARP inhibitor - Symptomatic and/or untreated CNS metastases - Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib |
Country | Name | City | State |
---|---|---|---|
France | Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard | Lyon | |
France | Hopital Saint-Louis | Paris | |
France | Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau | Saint-Herblain | |
France | Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | |
France | Institut Gustave Roussy | Villejuif | |
Germany | Urologische und Kinderurologische Universitätsklinik im Malteser | Erlangen | |
Germany | Universitatsklinikum Munster / Urologie und Kinderurologie | Münster | |
Germany | Studienpraxis Urologie | Nurtingen | |
Italy | Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS | Candiolo | |
Italy | Fondazione IRCCS Istituto Nazionale Tumori | Milano | |
Italy | IRCCS Ospedale San Raffaele - Medical Oncology Dept | Milano | |
Italy | Azienda Ospedaliera Universitaria Federico II Oncologia Medica | Naples | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron de Barcelona | Barcelona | |
Spain | Clinica Universitaria de Navarra Madrid | Madrid | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | MD Anderson Cancer Center | Madrid | |
Spain | Universidad de Navarra - Clinica Universitaria de Navarra | Pamplona | Navarre |
Spain | Hospital Clínico Universitario de Santiago de Compostela | Santiago De Compostela | |
United Kingdom | Guy's & St. Thomas' Hospital (London Oncology Clinic) | London | |
United Kingdom | Sarah Cannon Research Institute - United Kingdom - London Office | London | |
United States | New York Oncology Hematology, P.C. (USO - US Oncology) | Albany | New York |
United States | University of New Mexico UNM Cancer Research and Treatment Center | Albuquerque | New Mexico |
United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Maryland, Marlene and Stewart Greenebaum Cancer Center | Baltimore | Maryland |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Virginia, Emily Couric Clinical Center | Charlottesville | Virginia |
United States | University Oncology & Hematology | Chattanooga | Tennessee |
United States | Northwestern University, Chicago | Chicago | Illinois |
United States | Texas Oncology PA (USO - US Oncology) | Dallas | Texas |
United States | Duke University, Duke Cancer Institute | Durham | North Carolina |
United States | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey |
United States | Hartford Health Care Cancer Institute | Hartford | Connecticut |
United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
United States | University of Texas, UT Health Science Center | Houston | Texas |
United States | Indiana University - Melvin and Bren Simon Cancer Center (IUSCC) | Indianapolis | Indiana |
United States | The University of Iowa and Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of California San Diego (UCSD), Moores Cancer Center | La Jolla | California |
United States | Comprehensive Cancer Centers of Nevada (CCCN) | Las Vegas | Nevada |
United States | University of California, Los Angeles (UCLA) | Los Angeles | California |
United States | Norton Cancer Center | Louisville | Kentucky |
United States | Miami Cancer Institute, Baptist Health South Florida | Miami | Florida |
United States | Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Minnesota Oncology Hematology P.A. (USO - US Oncology) | Minneapolis | Minnesota |
United States | Atlantic Urology Clinics | Myrtle Beach | South Carolina |
United States | Urology Associates | Nashville | Tennessee |
United States | Ochsner Cancer Institute | New Orleans | Louisiana |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | New York - Presbyterian Hospital-Weill Cornell Medical Center | New York | New York |
United States | Eastern Connecticut Hematology & Oncology Associates (ECHO) | Norwich | Connecticut |
United States | Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | Universityof California, Irvine | Orange | California |
United States | Northwest Cancer Specialists P.C. (USO - US Oncology) | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Saint John's Health Center - John Wayne Cancer Institute (JWCI) | Santa Monica | California |
United States | Pinnacle Oncology, Honor Health | Scottsdale | Arizona |
United States | University of Washington / Seattle Cancer Care Alliance | Seattle | Washington |
United States | Stanford University School of Medicine | Stanford | California |
United States | Medstar Georgetown University Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
zr Pharma & GmbH | Foundation Medicine |
United States, France, Germany, Italy, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) Per RECIST Version 1.1 | ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Time from first dose to date of progression, up to approximately 19 months | |
Secondary | Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator | PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. | Cycle 1 Day 1 to End of Treatment, up to approximately 10 months | |
Secondary | Overall Survival | Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure). | The total study time for reporting of deaths was approximately 19 months. | |
Secondary | Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations | Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1. | From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06034015 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04235764 -
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
|
||
Completed |
NCT02371447 -
VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04081246 -
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
|
N/A | |
Recruiting |
NCT06059547 -
Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer
|
Phase 2 | |
Terminated |
NCT04779489 -
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer
|
N/A | |
Not yet recruiting |
NCT04493489 -
Propranolol Adjuvant Treatment of Bladder Cancer
|
Phase 2 | |
Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
Recruiting |
NCT04537221 -
Nordic Cystectomy Study III - Transfusion
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05562791 -
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
|
Phase 1 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT02781428 -
To Detect the Sensitivity of the UroMark Assay
|
||
Recruiting |
NCT04738630 -
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03978624 -
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
|
Phase 2 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A |