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ABTL0812 + FOLFIRINOX for Pancreatic Cancer (PanC-ASAP Trial)
PanC-ASAP Trial Summary
This trial is testing a new combination cancer treatment to see if it is effective and safe for people with metastatic pancreatic cancer.
PanC-ASAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPanC-ASAP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 528 Patients • NCT03504423PanC-ASAP Trial Design
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Who is running the clinical trial?
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- I have had a heart attack in the last 6 months or have serious heart issues.I have at least one tumor that can be measured and tracked for treatment response.I have been treated with a PI3K/Akt/mTOR pathway inhibitor.I am able to make my own health decisions and am not under legal supervision.I am fully active or can carry out light work.I am older than 18 years.My blood counts meet the required levels without needing transfusions.I can provide a recent sample of my tumor for testing.My cancer is not classified as carcinoma, adenocarcinoma, or ductal adenocarcinoma.I have a history of chronic diarrhea or inflammation in my colon or rectum, or unresolved blockages.I have active Hepatitis B/C, HIV, or Covid-19 that is not under control.My cancer has spread to other parts of my body.I can and will follow all study requirements.My cancer is advanced but hasn't spread far and can be surgically removed.I am using two effective forms of birth control during and 6 months after the study.I have had radiotherapy to the abdomen, but not for pain relief on target lesions.I had chemotherapy for early-stage cancer that was near vital organs.My cancer is a confirmed type of pancreatic cancer.
- Group 1: Arm B) PLACEBO + FOLFIRINOX
- Group 2: Arm A) ABTL0812 + FOLFIRINOX
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there still space available for volunteers to partake in this research?
"Clinicaltrials.gov confirms that this medical trial, which has been in existence since May 6th 2021, is still looking for candidates and was last updated on November 8th 2022."
Is the participation in this experiment restricted to seniors, or are those younger than 65 able to join?
"According to the criteria for participation, individuals aged 18-80 are eligible. For those under 18 and over 65 there are 5 and 391 clinical trials available respectively."
What prior research has encompassed the compound ABTL0812?
"At this moment, two studies are investigating the efficacy of ABTL0812. None of these research projects have reached Phase 3 yet. Furthermore, 14 distinct medical sites across Murcia and Galicia are conducting trials with this medication."
What are the key aims of this clinical investigation?
"This 6-month study seeks to establish the maximum tolerated dose of this medication, which is referred to as RP2D. The primary outcomes considered are Adverse Events categorised by CTCAE v5.0 and Overall Survival (OS 1y), while PFS using RECIST v1.1 will be collected for investigator analysis."
Is this an unprecedented research project?
"ABTL0812 has been studied since 2020, beginning with Ability Pharmaceuticals SL's Phase 1 & 2 trial. From there, two active studies were conducted in 5 cities across 3 nations and ABTL0812 received its drug approval."
How many participants are currently receiving treatment as part of this experiment?
"In order for this medical trial to be successful, 150 qualified participants are needed. Those interested can join from University of Cincinnati in Ohio or University of Kansas Cancer Center in Westwood, Kansas."
For whom is enrollment in this experiment permissible?
"This research endeavour seeks 150 individuals aged between 18-80 that have been diagnosed with malignant neoplasm of the pancreas. Additionally, participants must meet other criteria such as ECOG Performance Status 0-1, platelet count ≥ 100x109/L without transfusion support, hemoglobin ≥ 10 g/dL, measurable disease per RECIST Version 1.1 guidelines with at least one target lesion to evaluate response and more conditions for consideration in this study."
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