Status:
TERMINATED
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis
Lead Sponsor:
AbbVie
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in part...
Detailed Description
Study study was terminated before the Phase 2 portion of the study began.
Eligibility Criteria
Inclusion
- Body weight \>= 35 kg.
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
- Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
- Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.
Exclusion
- Participants with locally advanced disease.
- Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
- Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
- Prior radiotherapy to any measurable metastatic lesion at any time.
- Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
- Known metastases to the central nervous system (CNS).
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04807972
Start Date
May 28 2021
End Date
March 25 2024
Last Update
January 7 2025
Active Locations (15)
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1
UCHSC Anschultz Cancer Pavilion /ID# 227841
Aurora, Colorado, United States, 80045-2517
2
Johns Hopkins Hospital /ID# 226713
Baltimore, Maryland, United States, 21287
3
Univ Hosp Cleveland /ID# 226807
Cleveland, Ohio, United States, 44106
4
Cleveland Clinic Main Campus /ID# 231135
Cleveland, Ohio, United States, 44195