Vizsgálat az intravénás (IV) telisotuzumab adizutecan fluorouracil, folinsav és oxaliplatinnal (FOLFOX) kombinációjának értékelésére a szokásos kezeléssel szemben első vonalú metastatikus pancreatoductalis adenocarcinomában szenvedő felnőtt résztvevőknél
2./3. fázisú, nyílt címkézésű, randomizált vizsgálat a telisotuzumab adizutecan FOLFOX-kombinációjáról a standard kezeléshez képest elsővonalas, metastatikus hasnyálmirigyi duktális adenokarcinómában szenvedő alanyoknál - AndroMETa-PDAC-288
Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide.
Phase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + FOLFOX. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with FOLFOX or SOC. At the start of Phase 3, participants will receive the optimal dose of IV telisotuzumab adizutecan with FOLFOX or SOC. The study will run for a duration of approximately 6 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 2. fázis
- 3. fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: ABBVIE CALL CENTER
- Telefonszám: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Tanulmányi helyek
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Victoria
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Melbourne, Victoria, Ausztrália, 3084
- Toborzás
- Austin Hospital /ID# 280283
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Dél -Korea, 03080
- Toborzás
- Seoul National University Hospital /ID# 280191
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Oxfordshire
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Oxford, Oxfordshire, Egyesült Királyság, OX3 7LE
- Toborzás
- Oxford University Hospital NHS Trust /ID# 279764
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Connecticut
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New Haven, Connecticut, Egyesült Államok, 06511
- Toborzás
- Smilow Cancer Center At Yale-New Haven /ID# 279780
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Illinois
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Chicago, Illinois, Egyesült Államok, 60637
- Toborzás
- University of Chicago Medical Center /ID# 279460
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Zion, Illinois, Egyesült Államok, 60099
- Toborzás
- City Of Hope - Chicago /ID# 279814
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Michigan
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Grand Rapids, Michigan, Egyesült Államok, 49503
- Toborzás
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853
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Missouri
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St Louis, Missouri, Egyesült Államok, 63110
- Toborzás
- Washington University /ID# 279890
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Ohio
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Cleveland, Ohio, Egyesült Államok, 44106
- Toborzás
- UH Seidman Cancer Center /ID# 279602
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Pennsylvania
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Philadelphia, Pennsylvania, Egyesült Államok, 19104
- Toborzás
- University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 280038
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Texas
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Tyler, Texas, Egyesült Államok, 75702
- Toborzás
- Texas Oncology - Northeast Texas /ID# 280417
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Virginia
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Fairfax, Virginia, Egyesült Államok, 22031
- Toborzás
- Virginia Cancer Specialists - Fairfax /ID# 280415
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Haifa, Izrael, 3109601
- Toborzás
- Rambam Health Care Campus- Haifa /ID# 279409
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Jerusalem, Izrael, 91120
- Toborzás
- Hadassah Medical Center-Hebrew University /ID# 279411
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Tel Aviv
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Ramat Gan, Tel Aviv, Izrael, 5265601
- Toborzás
- The Chaim Sheba Medical Center /ID# 279408
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Tel Aviv, Tel Aviv, Izrael, 6423906
- Toborzás
- Tel Aviv Sourasky Medical Center /ID# 279414
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Tokyo
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Koto-ku, Tokyo, Japán, 135-8550
- Toborzás
- The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 280140
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Lisbon, Portugália, 1649-035
- Toborzás
- Unidade Local de Saude de Santa Maria /ID# 279884
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Lisbon District
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Lisbon, Lisbon District, Portugália, 1400-038
- Toborzás
- Fundacao Champalimaud /ID# 279881
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Kaohsiung City, Tajvan, 807
- Toborzás
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 279735
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Taichung, Tajvan, 40447
- Toborzás
- China Medical University Hospital /ID# 279725
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Taipei, Tajvan, 112
- Toborzás
- Taipei Veterans General Hospital /ID# 279726
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Must consent to provide archived or recently obtained tumor tissue during Screening
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria:
- Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting
- Prior c-MET targeting therapy
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Szekvenciális hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Ph 2: Dose Escalation Telisotuzumab Adizutecan + FOLFOX
Participants will receive Telisotuzumab Adizutecan + fluorouracil, folinic acid, and oxaliplatin (FOLFOX) until doses for optimization are determined, as part of an approximately 2 year study period. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
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Kísérleti: Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose A
Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
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Kísérleti: Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose B
Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
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Aktív összehasonlító: Ph 2: Dose Optimization Standard of Care (SOC) mFOLFIRINOX
Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
IV Infusion IV Infusion IV Infusion IV Infusion |
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Kísérleti: Ph 3: Telisotuzumab Adizutecan RP3D + FOLFOX
Participants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
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Aktív összehasonlító: Ph 3: SOC mFOLFIRINOX
Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
IV Infusion IV Infusion IV Infusion IV Infusion |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Időkeret: through study completion, approximately 6 years
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OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1. |
through study completion, approximately 6 years
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Phase 3: Overall Survival (OS)
Időkeret: through study completion, approximately 6 years
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OS is defined as the time from date of randomization to the death from any cause. |
through study completion, approximately 6 years
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
Időkeret: through study completion, approximately 6 years
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PFS is defined as the time from the date of randomization or date of first dose of study treatment to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. |
through study completion, approximately 6 years
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Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1
Időkeret: through study completion, approximately 6 years
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DoR is defined as time from the initial response of Complete Response or Partial Response assessed by BICR per RECIST v1.1 to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. |
through study completion, approximately 6 years
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Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
Időkeret: through study completion, approximately 6 years
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CB is defined as a participant achieving best overall response of confirmed CR or confirmed PR, or SD (with a minimum duration of 24 weeks) assessed by BICR per RECIST v1.1. |
through study completion, approximately 6 years
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Phase 2 : Overall Survival
Időkeret: through study completion, approximately 6 years
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OS is defined as the time from the date of randomization or date of first dose of study treatment to the event of death from any cause |
through study completion, approximately 6 years
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Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30-item (EORTC QLQ-C30)
Időkeret: through study completion, approximately 6 years
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The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
through study completion, approximately 6 years
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Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Pancreatic Cancer Module (EORTC QLQ-PAN26)
Időkeret: through study completion, approximately 6 years
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The EORTC QLQ-PAN is a PDAC-specific module and consists of 26 questions assessing pancreatic cancer- and treatment-related symptoms and impact, including 7 scales, and 10 single items, All questions employ a one week recall period, and each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
through study completion, approximately 6 years
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Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Időkeret: through study completion, approximately 6 years
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The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present). |
through study completion, approximately 6 years
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Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
Időkeret: through study completion, approximately 6 years
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The FACT GP5 item ("I am bothered by side effects of treatment") is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on patients. This item is rated on a 5- point Likert scale from 0="not at all" to 4="very much." |
through study completion, approximately 6 years
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Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)
Időkeret: through study completion, approximately 6 years
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The PGIS scale asks the participant to assess the severity of their PDAC symptoms over the past 7 days and employs a 5-point response scale ranging from "None" to "Very Severe". |
through study completion, approximately 6 years
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Phase 3: Change in Selected items of Patient Global Impression of Change (PGIC)
Időkeret: through study completion, approximately 6 years
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The PGIC scale assesses patients' perceptions of change in their PDAC symptoms since the start of treatment in the study and employs a 7-point response scale ranging from "Much Better" to "Much worse". |
through study completion, approximately 6 years
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Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L)
Időkeret: through study completion, approximately 6 years
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The EQ-5D-5L is a generic preference instrument that has been validated in numerous cancer populations. The EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ VAS records the participant's self-rated health on a vertical VAS where 100 represents "The best health you can imagine" and 0 represents "The worst health you can imagine." |
through study completion, approximately 6 years
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi igazgató: ABBVIE INC., AbbVie
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Szerves vegyi anyagok
- Heterociklusos vegyületek, 1 gyűrű
- Heterociklusos vegyületek
- Heterociklusos vegyületek, 2 gyűrű
- Heterociklusos vegyületek, olvasztott gyűrű
- Camptothecin
- Alkaloidok
- Enzimek és koenzimek
- Koordinációs komplexek
- Pirimidinek
- Formil -tetrahidrofolátumok
- Tetrahidrofolátumok
- Folsav
- Pterins
- Pteridinek
- Uracil
- Pirimidinonok
- Koenzimek
- Oxaliplatin
- Irinotekán
- Fluorouracil
- Leucovorin
Egyéb vizsgálati azonosító számok
- M25-288
- 2025-522563-15-00 (Egyéb azonosító: EU CT)
- 2025 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD megosztási időkeret
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-megosztási hozzáférési feltételek
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
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