BridgeMD
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 cancer
EU CTIS ID: 2024-515379-36-00
What this study is testing
- For Phase I: Safety of ABTL0812 plus FOLFIRINOX. - For Phase II: To determine the efficacy of ABTL0812 in combination with FOLFIRINOX vs. FOLFIRINOX plus placebo by progression free survival (PFS) according to central review.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.
- AST (SGOT) and ALT (SGPT) ≤ 2.5 times x upper limit of normal (≤ 5 times the ULN in patients with evidence of liver metastases).
- Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases).
- Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2.
- Only for Phase II patients. If available, a sample of tumor tissue or cytology (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided.
- For Spain. Contraception: All premenopausal female patients must use contraception. Male patients and their female partners (if fertile), must use contraception as well. In both cases, contraception means two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
You likely can't join if
- Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc).
- 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.
- Patient has active Hepatitis B or C, human immunodeficiency virus (HIV) or Covid-19 infection with non-controlled disease according to the treating physician.
- For France. Patients with complete absence of dihydropyrimidine dehydrogenase (DPD), defined as blood uracil level ≥150 ng/ml.
- Patients unable to provide informed consent like those under administrative or legal supervision.
- Patients has only locally advanced disease, resectable or borderline resectable.
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.
- AST (SGOT) and ALT (SGPT) ≤ 2.5 times x upper limit of normal (≤ 5 times the ULN in patients with evidence of liver metastases).
- Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases).
- Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2.
- Only for Phase II patients. If available, a sample of tumor tissue or cytology (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided.
- For Spain. Contraception: All premenopausal female patients must use contraception. Male patients and their female partners (if fertile), must use contraception as well. In both cases, contraception means two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
- For France. Contraception: All premenopausal female patients must use contraception. Male patients and their female partners (if fertile), must use contraception as well. Contraception means two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug, and female patient should extend contraception measures up to 9 months of last chemotherapy session with oxaliplatin.
- Willing and able to provide informed consent.
- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol.
- Confirmed metastatic disease.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Age, older than 18 years old.
- For Spain. Adequate hematologic function, measured as: absolute neutrophil count ≥ 1.5x10^9/L, platelet count ≥ 100x10^9/L without transfusion support and hemoglobin ≥ 10 g/dL.
- For France. Adequate hematologic function, measured as: absolute neutrophil count ≥ 2.0x10^9/L, platelet count ≥ 100x10^9/L without transfusion support and hemoglobin ≥ 10 g/dL.
- Total bilirubin ≤ 1.5 x ULN.
- Albumin ≥ 3.3 g/dL.
What rules you out
- Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc).
- 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.
- Patient has active Hepatitis B or C, human immunodeficiency virus (HIV) or Covid-19 infection with non-controlled disease according to the treating physician.
- For France. Patients with complete absence of dihydropyrimidine dehydrogenase (DPD), defined as blood uracil level ≥150 ng/ml.
- Patients unable to provide informed consent like those under administrative or legal supervision.
- Patients has only locally advanced disease, resectable or borderline resectable.
- The patient has received chemotherapy as adjuvant therapy for locally advanced disease, resectable or borderline resectable.
- Patient has received previous abdominal radiotherapy, (with the exception of analgesic radiotherapy that was not performed on target lesions).
- Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway by a systemic route.
- History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion not resolved under symptomatic treatment.
- Patient is pregnant or in lactation period. High sensitivity pregnancy test (urine or serum) to be performed within 7 days before study treatment starts.
- 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.
- 12-lead ECG with clinically relevant abnormality or showing a QTcF >450 ms, PR >210 ms, or QRS >120 ms at screening.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.