150 Participants Needed

ABTL0812 + FOLFIRINOX for Pancreatic Cancer

(PanC-ASAP Trial)

Recruiting at 23 trial locations
MC
Overseen ByMarc Cortal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ABTL0812, combined with usual chemotherapy for patients with advanced pancreatic cancer. The goal is to see if ABTL0812 can make the chemotherapy more effective. The study includes two stages: an initial stage to find the best amount and a second stage to compare the new combination against usual care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What safety data exists for FOLFIRINOX in humans?

FOLFIRINOX has been used since 2010 for treating pancreatic cancer, and while it can cause side effects that sometimes require reducing the dose, it has been widely adopted in clinical practice. Studies have focused on managing these side effects and adjusting treatment to improve safety.12345

What makes the ABTL0812 + FOLFIRINOX treatment unique for pancreatic cancer?

The combination of ABTL0812 with FOLFIRINOX is unique because it adds a novel drug, ABTL0812, to the standard FOLFIRINOX regimen, which is already known for its effectiveness in improving survival and quality of life in pancreatic cancer patients. This combination aims to enhance the treatment's efficacy by potentially introducing a new mechanism of action alongside the established benefits of FOLFIRINOX.35678

What data supports the effectiveness of the drug FOLFIRINOX for pancreatic cancer?

FOLFIRINOX has been shown to improve survival and quality of life in patients with metastatic pancreatic cancer compared to gemcitabine, according to the PRODIGE 4/ACCORD 11 study. It is a standard first-line treatment for advanced pancreatic cancer, despite concerns about its side effects.3591011

Who Is on the Research Team?

MC

Marc Cortal

Principal Investigator

Ability Pharmaceuticals SL

Are You a Good Fit for This Trial?

Adults with confirmed metastatic pancreatic cancer, good blood counts and organ function, who haven't been treated with PI3K/Akt/mTOR pathway inhibitors. They must not have other serious medical conditions or a history of certain heart diseases. Participants need to use effective contraception and be able to follow the study protocol.

Inclusion Criteria

I have at least one tumor that can be measured and tracked for treatment response.
Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2
Total bilirubin ≤ 1.5 x ULN, Albumin ≥ 3.3 g/dL
See 11 more

Exclusion Criteria

I have had a heart attack in the last 6 months or have serious heart issues.
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.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Open label phase to determine the RP2D of ABTL0812 in combination with FOLFIRINOX with dose de-escalation

5 weeks
Weekly visits for dose adjustment and monitoring

Phase II Treatment

Double blind, randomized, placebo-controlled study to evaluate ABTL0812 in combination with FOLFIRINOX

Until disease progression or unacceptable toxicities
Bi-weekly visits for chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Quarterly visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • ABTL0812
  • Folfirinox
  • Placebo
Trial Overview The trial is testing ABTL0812 in combination with FOLFIRINOX chemotherapy as a first-line treatment for metastatic pancreatic cancer. It's an open-label Phase I followed by a randomized Phase II study comparing this combination against placebo plus FOLFIRINOX.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm B) PLACEBO + FOLFIRINOXExperimental Treatment2 Interventions
Group II: Arm A) ABTL0812 + FOLFIRINOXExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ability Pharmaceuticals SL

Lead Sponsor

Trials
4
Recruited
340+

Published Research Related to This Trial

FOLFIRINOX (FFX) has been shown to significantly improve median overall survival, progression-free survival, and objective response rates in patients with metastatic pancreatic cancer compared to gemcitabine, as established in the PRODIGE 4/ACCORD 11 study.
Despite initial concerns about its toxicity, FFX has been widely adopted in clinical practice, leading to new research opportunities and discussions about managing its side effects and optimizing treatment protocols.
Pancreatic cancer and FOLFIRINOX: a new era and new questions.Marsh, Rde W., Talamonti, MS., Katz, MH., et al.[2023]
In a study of 71 patients with advanced pancreatic cancer who progressed after initial treatment with modified FOLFIRINOX, second-line chemotherapy resulted in a 7.1% partial response rate and a 27.1% disease stabilization rate.
The median overall survival for these patients was 6.2 months, with CA19.9 levels above the normal limit indicating worse survival outcomes, suggesting that certain prognostic factors can help identify patients who may benefit more from salvage chemotherapy.
Second-line therapy for advanced pancreatic cancer: evaluation of prognostic factors and review of current literature.Caparello, C., Vivaldi, C., Fornaro, L., et al.[2022]
In a multicenter phase II study involving 31 patients with locally advanced pancreatic cancer (LAPC) and 44 with metastatic pancreatic cancer (MPC), modified FOLFIRINOX showed comparable efficacy to full-dose FOLFIRINOX in MPC, with a response rate of 35.1% and a median overall survival of 10.2 months.
The study found that modified FOLFIRINOX significantly reduced adverse events such as neutropenia, vomiting, and fatigue, while demonstrating notable efficacy in LAPC with a median progression-free survival of 17.8 months and overall survival of 26.6 months.
Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.Stein, SM., James, ES., Deng, Y., et al.[2022]

Citations

Pancreatic cancer and FOLFIRINOX: a new era and new questions. [2023]
Second-line therapy for advanced pancreatic cancer: evaluation of prognostic factors and review of current literature. [2022]
Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. [2022]
Association of Modified-FOLFIRINOX-Regimen-Based Neoadjuvant Therapy with Outcomes of Locally Advanced Pancreatic Cancer in Chinese Population. [2023]
Population pharmacokinetics of FOLFIRINOX: a review of studies and parameters. [2019]
Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer. [2020]
Chemoradiation after FOLFIRINOX for borderline resectable or locally advanced pancreatic cancer. [2022]
FOLFIRINOX relative dose intensity and disease control in advanced pancreatic adenocarcinoma. [2022]
Neoadjuvant FOLFIRINOX in Patients With Borderline Resectable Pancreatic Cancer: A Systematic Review and Patient-Level Meta-Analysis. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A UGT1A1 genotype-guided dosing study of modified FOLFIRINOX in previously untreated patients with advanced gastrointestinal malignancies. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Validated Nomogram Predicting 6-Month Survival in Pancreatic Cancer Patients Receiving First-Line 5-Fluorouracil, Oxaliplatin, and Irinotecan. [2020]
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