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NCT04431258 · ClinicalTrials.gov registry record · Phase 1
ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study
A Phase 1 study of Pancreatic Cancer, sponsored by Ability Pharmaceuticals SL.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04431258: Completed Phase 1 study of Pancreatic Cancer, sponsored by Ability Pharmaceuticals SL.
NCT04431258 is a Phase 1 study of Pancreatic Cancer that has completed, run by Ability Pharmaceuticals SL. The registered enrollment target is 150 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04431258, a Phase 1 study of Pancreatic Cancer, has completed, sponsored by Ability Pharmaceuticals SL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.
Primary Outcome
Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Folfirinox
- DRUG ABTL0812
Study Locations (20)
Other
- CGFL Dijon - Dijon
- Institute Paoli-Calmettes - Marseille
- Institut Gustave Roussy - Villejuif
- Rabam MC - Haifa
- Shaare Zedek MC - Jerusalem
- Sheba MC - Ramat Gan
- Hospital General Universitario Dr. Balmis - Alicante
- Hospital Quiron Salud - Barcelona
- Vall d'Hebron University Hospital - Barcelona
- ICO Girona - Girona
- Hospital Universitari Arnau de Vilanova - Lleida
- Hospital Gregorio Marañón - Madrid
- Hospital Universitario 12 de Octubre - Madrid
- Hospital General Universitario Morales Meseguer - Murcia
California
- Cedars Sinai - Los Angeles
Kansas
- University of Kansas Cancer Center - Westwood
Massachusetts
- Massachusetts General Hospital - Boston
Ohio
- University of Cincinnati - Cincinnati
Barcelona
- ICO Badalona - Badalona
Galicia
- Centro Oncológico de Galicia - A Coruña
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2024-01-10 |
| Phase | Phase 1 |
What the finished NCT04431258 record still lists
NCT04431258 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04431258 names 20 study sites across 7 states, led by Other, California, Kansas.
Frequently Asked Questions
What is clinical trial NCT04431258 about?
NCT04431258 is a clinical study titled "ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study". A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Phar...
What is the current status of trial NCT04431258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2021-05-06. Estimated completion is 2024-01-10.
What conditions does trial NCT04431258 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT04431258?
The interventions under investigation include: Placebo (DRUG), Folfirinox (DRUG), ABTL0812 (DRUG).
Who is sponsoring clinical trial NCT04431258?
This trial is sponsored by Ability Pharmaceuticals SL, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04431258 being conducted?
This trial has 20 study locations across California, Kansas, Massachusetts, Ohio, Barcelona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04431258's enrollment target sits among peer trials
150 79th of 278 higher than 198 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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