A Study of ABTL0812 in Pancreatic Cancer

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Brief Title

A Study of ABTL0812 in Pancreatic Cancer

Official Title

A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy

Brief Summary

      A Randomized Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in
      Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic
      Pancreatic Cancer at First Line Therapy.
    

Detailed Description

      This is an open-label, randomized phase I/II multicenter study to evaluate ABTL0812 in
      combination with gemcitabine and nab-paclitaxel at first line therapy. Patients will be
      assigned to the following groups during the study conduct:

        -  GROUP A: You will receive the standard treatment of chemotherapy and the investigational
           drug ABTL0812.

        -  GROUP B: You will receive the standard treatment of chemotherapy.

      For GROUP A:

      Phase I: A 3+3 de-escalation design followed by an expansion phase will be performed

        -  ABTL0812 will be administered chronically daily. Potential dose levels are 1300 mg tid,
           1000 mg tid, 650 mg tid and 500 mg tid. Intrapatient escalation or de-escalation is not
           permitted. A run-in period of one week for ABTL0812 is planned before starting the first
           cycle of chemotherapy.

        -  Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 +
           nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.

        -  If any, or all, the components of the chemotherapeutic regimen must be interrupted for
           any reason (excluding disease progression), ABTL0812 will be administered as maintenance
           therapy until disease progression, onset of unacceptable drug toxicities, or
           patient/physician's request to discontinue.

      Phase II:

        -  ABTL0812 will be administered chronically daily at the Recommended Phase 2 Dose (RP2D).
           A run-in period of one week for ABTL0812 is planned before starting the first cycle of
           chemotherapy.

        -  Chemotherapy will be administered on 28-day cycles: gemcitabine 1000 mg/m2 IV +
           nab-paclitaxel 125 mg/m2 IV on days 1, 8 and 15

        -  If any, or all, the components of the chemotherapeutic regimen must be interrupted for
           any reason (excluding disease progression), ABTL0812 will be administered as maintenance
           therapy until disease progression, onset of unacceptable drug toxicities, or
           patient/physician's request to discontinue.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Emergent Adverse Events


Condition

Pancreatic Cancer

Intervention

ABTL0812

Study Arms / Comparison Groups

 ARM A
Description:  ABTL0812 (starting 1,300 mg tid orally) in combination with gemcitabine and nab-paclitaxel will be administered to patients with pancreatic cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

110

Start Date

December 1, 2019

Completion Date

March 30, 2023

Primary Completion Date

March 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ≥18 years of age

          -  Willing and able to provide informed consent

          -  Ability and willingness to comply with study visits, treatment, testing, and to comply
             with the protocol

          -  Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the
             pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be
             made by integrating the histopathological data within the context of the clinical and
             radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis
             of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.

          -  Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is
             allergic to CT contrast media).

          -  Patient has not received previous radiotherapy, surgery, chemotherapy or
             investigational therapy for the treatment of metastatic disease. Prior treatment with
             5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is
             allowed, provided at least 6 months have elapsed since completion of the last dose and
             no lingering toxicities are present.

          -  Patient has not received cytotoxic doses of gemcitabine or any other chemotherapy in
             the adjuvant setting

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

          -  Adequate hematologic function, measured as:

               -  absolute neutrophil count ≥ 1.5x109/L

               -  platelet count ≥ 100x109/L

               -  hemoglobin ≥ 9.0 g/dL

          -  Total bilirubin ≤ 1.5 x ULN

          -  Albumin ≤ 1.5 x ULN AST (SGOT) ≤ 2.5 times x upper limit of normal (ULN) 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)

          -  Serum creatinine ≤1.5 ULN

          -  Have adequate tumor tissue available (either archival or new tumor biopsy) for
             biomarker analyses. The most recently collected tumor tissue sample should be
             provided, if available.

          -  Life expectancy ≥ 12 weeks in the opinion of the investigator

          -  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

          -  Contraception: All female patients will be considered to be of childbearing potential
             unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the
             appropriate age group and without other known or suspected cause), or have been
             sterilized surgically. Female patients of childbearing potential must agree to use two
             forms of highly effective contraception methods during the study and for a period of 6
             months following the last administration of the study drug. Male patients and their
             female partners, who are of childbearing potential and are not practicing total
             abstinence, must agree to use two forms of highly effective contraception during the
             study and for a period of 6 months following the last administration of the study
             drug.

          -  Toxicities incurred as a result of previous anticancer therapy (radiation therapy,
             chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common
             Terminology Criteria for Adverse Events version 4.03).

        Exclusion Criteria:

        Inclusion criteria:

        Patients fulfilling the following criteria are eligible for participation in the study:

          -  Patients ≥18 years of age

          -  Willing and able to provide informed consent

          -  Ability and willingness to comply with study visits, treatment, testing, and to comply
             with the protocol

          -  Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the
             pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be
             made by integrating the histopathological data within the context of the clinical and
             radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis
             of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.

          -  Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is
             allergic to CT contrast media).

          -  Patient has not received previous radiotherapy, surgery, chemotherapy or
             investigational therapy for the treatment of metastatic disease. Prior treatment with
             5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is
             allowed, provided at least 6 months have elapsed since completion of the last dose and
             no lingering toxicities are present.

          -  Patient has not received cytotoxic doses of gemcitabine or any other chemotherapy in
             the adjuvant setting

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

          -  Adequate hematologic function, measured as:

               -  absolute neutrophil count ≥ 1.5x109/L

               -  platelet count ≥ 100x109/L

               -  hemoglobin ≥ 9.0 g/dL

          -  Total bilirubin ≤ 1.5 x ULN

          -  Albumin ≤ 1.5 x ULN AST (SGOT) ≤ 2.5 times x upper limit of normal (ULN) 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)

          -  Serum creatinine ≤1.5 ULN

          -  Have adequate tumor tissue available (either archival or new tumor biopsy) for
             biomarker analyses. The most recently collected tumor tissue sample should be
             provided, if available.

          -  Life expectancy ≥ 12 weeks in the opinion of the investigator

          -  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

          -  Contraception: All female patients will be considered to be of childbearing potential
             unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the
             appropriate age group and without other known or suspected cause), or have been
             sterilized surgically. Female patients of childbearing potential must agree to use two
             forms of highly effective contraception methods during the study and for a period of 6
             months following the last administration of the study drug. Male patients and their
             female partners, who are of childbearing potential and are not practicing total
             abstinence, must agree to use two forms of highly effective contraception during the
             study and for a period of 6 months following the last administration of the study
             drug.

          -  Toxicities incurred as a result of previous anticancer therapy (radiation therapy,
             chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common
             Terminology Criteria for Adverse Events version 4.03).

        Exclusion criteria:

        Patients who meet one of more of the following criteria are not eligible:

          -  Patients with neuroendocrine tumors or cystic neoplasms are excluded

          -  Patient has received previous radiotherapy, surgery, chemotherapy or investigational
             therapy for the treatment of metastatic disease. Prior treatment with 5-FU or
             gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed,
             provided at least 6 months have elapsed since completion of the last dose and no
             lingering toxicities are present. Patients having received cytotoxic doses of
             gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for
             this study

          -  Patient has only locally advanced disease.

          -  Patients has symptomatic brain metastases. Patients with asymptomatic brain metastases
             can be included in the study if they are kept on stable doses of steroids for a period
             of 1 month prior to study entry provided they don't have peripheric neuropathy grade 2
             or superior.

          -  Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway

          -  Patients has gastrointestinal abnormalities including inability to take oral
             medications, malabsorption syndromes or other clinically significant gastrointestinal
             abnormalities that may impair the absorption of the investigational medicinal product.

          -  Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to
             study treatment start.

          -  Patients had myocardial infarction within ≤ 12 months prior to study entry,
             symptomatic congestive heart failure (New York Heart Association > class II), unstable
             angina pectoris, or unstable cardiac arrhythmia requiring medication.

          -  Evidence of pre-existing uncontrolled hypertension. Patients whose hypertension is
             controlled by antihypertensive therapies are eligible.

          -  Patients has active Hepatitis B or C or human immunodeficiency virus (HIV) infection
             with non-controlled disease according to the treating physician.

          -  Patients with any other medical conditions (such as psychiatric illness, 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Davendra Sohal, +93603141706, [email protected]



Administrative Informations


NCT ID

NCT03417921

Organization ID

ABT-C6-2017


Responsible Party

Sponsor

Study Sponsor

Ability Pharmaceuticals SL

Collaborators

 The Cleveland Clinic

Study Sponsor

Davendra Sohal, Principal Investigator, Cleveland Clinics


Verification Date

January 2019