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Status:

COMPLETED

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

Lead Sponsor:

Ability Pharmaceuticals SL

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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....

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 ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.
  • 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
  • Adequate hematologic function, measured as:
  • absolute neutrophil count ≥ 1.5x109/L
  • platelet count ≥ 100x109/L without transfusion support
  • hemoglobin ≥ 10 g/dL
  • Total bilirubin ≤ 1.5 x ULN
  • Albumin ≥ 3.3 g/dL
  • 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 m2
  • 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.
  • 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.
  • Willing and able to provide informed consent
  • Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol.
  • Exclusion criteria
  • Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc)
  • 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.
  • 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.
  • Patients unable to provide informed consent like those under administrative or legal supervision

Exclusion

    Key Trial Info

    Start Date :

    May 6 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 10 2024

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT04431258

    Start Date

    May 6 2021

    End Date

    January 10 2024

    Last Update

    March 18 2024

    Active Locations (24)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (24 locations)

    1

    Cedars Sinai

    Los Angeles, California, United States, 90048

    2

    University of Kansas Cancer Center

    Westwood, Kansas, United States, 66205-0000

    3

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    4

    University of Cincinnati

    Cincinnati, Ohio, United States, 45267