KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT ID: NCT05027867
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2021-12-06
2022-08-26
Brief Summary
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This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
KRT-232
Administered by mouth
Arm 2
KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
KRT-232
Administered by mouth
Interventions
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KRT-232
Administered by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease must be measurable per RECIST Version 1.1
* Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
* Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
* ECOG ≤ 2
Exclusion Criteria
* Prior treatment with MDM2 inhibitors
* Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
* Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
* History of major organ transplant
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Florida Cancer Specialists - 3840 Broadway
Fort Myers, Florida, United States
Florida Cancer Specialists - 560 Jackson St, Suite 220
St. Petersburg, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Mark H Zangmeister Center - 3100 Plaza Properties Boulevard
Columbus, Ohio, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, United States
Flinders Medical Centre
Bedford Park, South Australia, Australia
Centre Hospitalier de Mulhouse - Hopital Emile Muller
Mulhouse, France/Haut-Rhin, France
Edog - Ico - Ppds
Angers, Maine-et-Loire, France
Hôpital Louis Pradel
Bron, Rhône, France
Hospices Civils de Lyon
Lyon, Rhône, France
Hôpital de La Croix Rousse
Pierre-Bénite, Rhône, France
EDOG - Institut Bergonie - PPDS
Bordeaux, , France
CHU de Grenoble
Grenoble, , France
Hopital Nord AP-HM
Marseille, , France
Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, Baden-Wurttemberg, Germany
Lungenfachklinik Immenhausen
Immenhausen, Hesse, Germany
Evangelische Lungenklinik Berlin
Berlin, , Germany
Bacs Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, Hungary
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Universitario 12 de Octubre
Alicante, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, , Spain
Clinica Universidad Navarra - Madrid
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital Civil
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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KRT-232-112
Identifier Type: -
Identifier Source: org_study_id
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