Clinical Trials /

A Study to Test the Effectiveness of ABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System

NCT03670030

Description:

The purpose of this study is to determine whether ABI-009 will make advanced, malignant neuroendocrine tumor(s) of the lung, gastrointestinal tract and/or pancreas that cannot be removed by surgery smaller and slow the spread of your cancer in patients who have progressed or been intolerant to everolimus. All eligible participants will receive ABI-009, the study drug.

Related Conditions:
  • Gastrointestinal Neuroendocrine Tumors
  • Lung Carcinoid Tumor
  • Lung Neuroendocrine Neoplasm
  • Pancreatic Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Test the Effectiveness of ABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System
  • Official Title: A Pilot Phase 2 Study of Albumin-bound Rapamycin Nanoparticles, ABI-009, in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System

Clinical Trial IDs

  • ORG STUDY ID: NET-001
  • NCT ID: NCT03670030

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
ABI-009nab-rapamycinABI-009

Purpose

The purpose of this study is to determine whether ABI-009 will make advanced, malignant neuroendocrine tumor(s) of the lung, gastrointestinal tract and/or pancreas that cannot be removed by surgery smaller and slow the spread of your cancer in patients who have progressed or been intolerant to everolimus. All eligible participants will receive ABI-009, the study drug.

Detailed Description

      ABI-009, human albumin-bound rapamycin, is an experimental drug. "Experimental" means that
      the drug has not been approved by the Food and Drug Administration (FDA).

      Rapamycin, the active part of the drug, inhibits a biological pathway (mTOR) that certain
      cancers use to grow. Rapamycin and similar types of drugs have been used in many other
      tumors, including advanced renal cell carcinoma. A standard mTOR inhibitor used in
      neuroendocrine tumors is everolimus. The human albumin component of ABI-009 may allow
      rapamycin to reach cancer cells more effectively.

      ABI-009 has not been approved for the treatment of advanced, malignant neuroendocrine tumors
      of the lung, gastrointestinal tract and/or pancreas. The information from this study might
      help us identify if ABI-009 is safe and effective in this disease.
    

Trial Arms

NameTypeDescriptionInterventions
ABI-009ExperimentalIn this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.
  • ABI-009

Eligibility Criteria

        Inclusion Criteria:

          1. Unresectable or metastatic patients with typical or atypical carcinoid tumors of the
             lung or low or intermediate grade gastroenteropancreatic neuroendocrine tumors
             (GEPNETs).

          2. Patients must have measurable disease per RECIST 1.1.

          3. Patients must have progressed on everolimus or been intolerant to everolimus.

          4. Patients, ≥18 years old, must have Eastern Cooperative Oncology Group (ECOG)
             Performance Status 0 or 1.

          5. Concurrent use of somatostatin analogs (SSAs) is allowed if currently used for symptom
             control.

          6. Adequate liver function:

               1. Total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dL

               2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
                  (<5 x ULN if the patient has liver metastases).

          7. Adequate renal function:

             a. Serum creatinine ≤2 x ULN or creatinine clearance >50 cc/hr (Cockroft-Gault).

          8. Adequate biological parameters:

               1. Absolute neutrophil count (ANC) ≥1.5 × 109/L

               2. Platelet count ≥100,000/mm3 (100 × 109/L)

               3. Hemoglobin ≥9 g/dL.

          9. Fasting serum triglyceride ≤300 mg/dL; fasting serum cholesterol ≤350 mg/dL.

         10. Male or non-pregnant and non-breast feeding female:

               -  Females of child-bearing potential must agree to use effective contraception
                  without interruption from 28 days prior to starting investigational product (IP)
                  throughout 3 months after last dose of IP and have a negative serum pregnancy
                  test (β-hCG) result at screening and agree to ongoing pregnancy testing during
                  the course of the study, and after the end of study treatment. A second form of
                  birth control is required even if she has had a tubal ligation.

               -  Male patients must practice abstinence or agree to use a condom during sexual
                  contact with a pregnant female or a female of childbearing potential while
                  participating in the study and throughout 3 months after last dose of IP. A
                  second form of birth control is required even if he has undergone a successful
                  vasectomy.

         11. Life expectancy of >3 months, as determined by the investigator.

         12. Ability to understand and sign informed consent.

         13. Willingness and ability to comply with scheduled visits, laboratory tests, and other
             study procedures.

        Exclusion Criteria:

          1. Patients currently undergoing anti-cancer therapy for neuroendocrine tumors (other
             than SSAs for symptoms).

          2. History of allergic reactions to compounds of similar chemical or biologic composition
             to ABI-009.

          3. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A
             patient with controlled and asymptomatic CNS metastases may participate in this study.
             As such, the patient must have completed any prior treatment for CNS metastases ?28
             days (including radiotherapy and/or surgery) prior to start of treatment in this study
             and should not be receiving chronic corticosteroid therapy for the CNS metastases.

          4. Active gastrointestinal bleeding.

          5. Uncontrolled serious medical or psychiatric illness. Patients with a "currently
             active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of
             the cervix, resected incidental prostate cancer (staged pathological tumor-2 (pT2)
             with Gleason Score ≤6 and postoperative prostate-specific antigen (PSA) <0.5 ng/mL),
             or other adequately treated carcinoma-in-situ are ineligible. Patients are not
             considered to have a "currently active" malignancy if they have completed therapy and
             are free of disease for ≥1 year).

          6. Recent infection requiring systemic anti-infective treatment that was completed ≤14
             days prior to enrollment (with the exception of uncomplicated urinary tract infection
             or upper respiratory tract infection).

          7. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.

          8. Unstable coronary artery disease or myocardial infarction during preceding 6 months.

          9. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary
             hypertension.

         10. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving
             the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with
             narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride,
             dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to
             receiving the first dose of ABI-009.

         11. Known Human Immunodeficiency Virus (HIV).

         12. Known active Hepatitis B or Hepatitis C.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Control Rate
Time Frame:6 months
Safety Issue:
Description:Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Measure:Adverse Event Assessment
Time Frame:Continuous from the signing of the informed consent to 28 days after last study treatment
Safety Issue:
Description:Collection of any adverse events

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Robert Ramirez

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