Metastatic Pancreatic Ductal Adenocarcinoma, PDAC
Conditions
Keywords
Metastatic Pancreatic Ductal Adenocarcinoma, PDAC, Telisotuzumab adizutecan
Brief summary
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.
Interventions
Intravenous (IV) Infusion
DRUGFluorouracil
IV Infusion
DRUGFolinic acid/ Leucovorina
IV Infusion
DRUGOxaliplatin
IV Infusion
DRUGIrinotecan
IV Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | through study completion, approximately 6 years | 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. |
| Phase 3: Overall Survival (OS) | through study completion, approximately 6 years | OS is defined as the time from date of randomization to the death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1 | through study completion, approximately 6 years | 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. |
| Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1 | through study completion, approximately 6 years | 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. |
| Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1 | through study completion, approximately 6 years | 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. |
| Phase 2 : Overall Survival | through study completion, approximately 6 years | 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 |
| 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) | through study completion, approximately 6 years | 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). |
| 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) | through study completion, approximately 6 years | 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). |
| Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | through study completion, approximately 6 years | 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). |
| Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G) | through study completion, approximately 6 years | 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." |
| Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS) | through study completion, approximately 6 years | 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". |
| Phase 3: Change in Selected items of Patient Global Impression of Change (PGIC) | through study completion, approximately 6 years | 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". |
| Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) | through study completion, approximately 6 years | 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." |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed