Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670030
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Aadi, LLC
Information provided by (Responsible Party):
Robert Ramirez, Ochsner Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: ABI-009 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : November 1, 2020


Arm Intervention/treatment
Experimental: ABI-009
In 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.
Drug: ABI-009
rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Other Name: nab-rapamycin




Primary Outcome Measures :
  1. Disease Control Rate [ Time Frame: 6 months ]
    Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Adverse Event Assessment [ Time Frame: Continuous from the signing of the informed consent to 28 days after last study treatment ]
    Collection of any adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670030


Contacts
Layout table for location contacts
Contact: Heather Scuderi 504-703-2654 heather.scuderi@ochsner.org

Locations
Layout table for location information
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Robert Ramirez, DO       robert.ramirez@ochsner.org   
Contact: Sharon Jerdonek, RN       sharon.jerdonek@ochsner.org   
Sponsors and Collaborators
Robert Ramirez
Aadi, LLC
Investigators
Layout table for investigator information
Principal Investigator: Robert Ramirez, DO Ochnser Clinic Foundation

Layout table for additonal information
Responsible Party: Robert Ramirez, Principal Investigator, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03670030     History of Changes
Other Study ID Numbers: NET-001
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregate data will be made publicly available in the form of poster presentations or journal articles.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Lung Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs