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ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT04431258•Ability Pharmaceuticals SL

View on ClinicalTrials.gov

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.

Detailed Description

Phase I: This is an open label Phase I to determine the RP2D of ABTL0812 in combination with FOLFIRINOX. All patients will receive ABTL0812 in combination with FOLFIRINOX. A dose de-escalation phase will be performed in which up to 3 different ABTL0812 dose levels will be tested in combination with FOLFIRINOX. ABTL0812 doses are: 1300 mg tid (starting dose), followed (if necessary) by 975 mg tid and 650 mg tid. Patient intra-escalation is not allowed. Phase II: This is a double blind, randomized, placebo-controlled Phase II multicenter study to evaluate ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer. Patients will be randomized to one of two groups: arm A) receiving ABTL0812 in addition to FOLFIRINOX and arm B) receiving FOLFIRINOX plus placebo. Arm A) ABTL0812 + FOLFIRINOX Arm B) PLACEBO + FOLFIRINOX

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.
•2. Confirmed metastatic disease
•3. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one "target lesion" to be used to assess response. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented.
•4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
•5. Age, older than 18 years old
•6. Adequate hematologic function, measured as:
•* absolute neutrophil count ≥ 1.5x109/L
•* platelet count ≥ 100x109/L without transfusion support
•* hemoglobin ≥ 10 g/dL
•7. Total bilirubin ≤ 1.5 x ULN
+8 more criteria

Exclusion Criteria

•1. Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc)
•2. Patients has only locally advanced disease, resectable or borderline resectable.
•3. The patient has received chemotherapy as adjuvant therapy for locally advanced disease, resectable or borderline resectable.
•4. Patient has received previous abdominal radiotherapy, (with the exception of analgesic radiotherapy that was not performed on target lesions).
•5. Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway by a systemic route.
•6. History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion not resolved under symptomatic treatment
•7. Patient is pregnant or in lactation period. High sensitivity pregnancy test (urine or serum) to be performed within 7 days before study treatment starts.
•8. Patient had myocardial infarction within ≤ 6 months prior to study entry, LVEF \<50%, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
•9. 12-lead ECG with clinically relevant abnormality or showing a QTcF \>450 ms, PR \>210 ms, or QRS \>120 ms at screening.
•10. Patients with any other medical conditions (such as psychiatric illness, cardiovascular disease, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
+2 more criteria

Locations (24)

Cedars Sinai

Los Angeles, California, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Cincinnati

Cincinnati, Ohio, United States

CGFL Dijon

Dijon, France

Institute Paoli-Calmettes

Marseille, France

Institut Gustave Roussy

Villejuif, France

Rabam MC

Haifa, Israel

Shaare Zedek MC

Jerusalem, Israel

Sheba MC

Ramat Gan, Israel

Key Dates

Start Date

May 6, 2021

Primary Completion Date

January 10, 2024

Completion Date

January 10, 2024

Last Updated

March 18, 2024

Enrollment

150

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

ABTL0812

DRUG

Folfirinox

DRUG

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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