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NCT04753879 · ClinicalTrials.gov registry record · Phase 2
Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
A Phase 2 study of Metastatic Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04753879: Recruiting Phase 2 study of Metastatic Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04753879 is a Phase 2 study of Metastatic Pancreatic Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 38 participants, below the 106-participant average among 32 other Metastatic Pancreatic Cancer trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04753879, a Phase 2 study of Metastatic Pancreatic Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and clinical activity of maintenance olaparib and pembrolizumab following multi-agent, low dose chemotherapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with untreated metastatic pancreatic ductal cancer.
Primary Outcome
PFS is defined as the 6 month from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% incre
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Irinotecan
- DRUG Nab-paclitaxel
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 2 |
What NCT04753879 shows while recruiting
NCT04753879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 106-participant average among 32 other Metastatic Pancreatic Cancer trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Metastatic Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT04753879 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04753879 about?
NCT04753879 is a clinical study titled "Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.". The purpose of this study is to evaluate the safety and clinical activity of maintenance olaparib and pembrolizumab following multi-agent, low dose chemotherapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with untreated metastatic pancreatic ductal ...
What is the current status of trial NCT04753879?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-09-29. Estimated completion is 2029-12-01.
What conditions does trial NCT04753879 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Cancer.
What interventions are being tested in trial NCT04753879?
The interventions under investigation include: Capecitabine (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Irinotecan (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04753879?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04753879 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04753879's enrollment target sits among peer trials
38 15th of 32 higher than 18 of 32 other Metastatic Pancreatic Cancer trials
participants (enrollment target), bucketed by value
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