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Neuroendocrine TumorsPhase 2NCT03670030

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

A Phase 2 study testing ABI-009 in people with Neuroendocrine Tumors, run by Robert Ramirez at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
ABI-009
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
5 Nov 2018to 26 Feb 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unresectable or metastatic patients with typical or atypical carcinoid tumors of the lung or low or intermediate grade gastroenteropancreatic neuroendocrine tumors (GEPNETs).
  • Patients must have measurable disease per RECIST 1.1.
  • Patients must have progressed on everolimus or been intolerant to everolimus.
  • Patients, ≥18 years old, must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Concurrent use of somatostatin analogs (SSAs) is allowed if currently used for symptom control.
  • Adequate liver function:
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  • Total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (<5 x ULN if the patient has liver metastases).
  • Adequate renal function:
  • Serum creatinine ≤2 x ULN or creatinine clearance >50 cc/hr (Cockroft-Gault).
  • Adequate biological parameters:
  • Absolute neutrophil count (ANC) ≥1.5 × 109/L
  • Platelet count ≥100,000/mm3 (100 × 109/L)
  • Hemoglobin ≥9 g/dL.
  • Fasting serum triglyceride ≤300 mg/dL; fasting serum cholesterol ≤350 mg/dL.
  • 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.
  • Life expectancy of >3 months, as determined by the investigator.
  • Ability to understand and sign informed consent.
  • Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.

Who cannot join

  • Patients currently undergoing anti-cancer therapy for neuroendocrine tumors (other than SSAs for symptoms).
  • History of allergic reactions to compounds of similar chemical or biologic composition to ABI-009.
  • 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.
  • Active gastrointestinal bleeding.
  • 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).
  • 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).
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  • Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.
  • Unstable coronary artery disease or myocardial infarction during preceding 6 months.
  • Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
  • 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.
  • Known Human Immunodeficiency Virus (HIV).
  • Known active Hepatitis B or Hepatitis C.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ABI-009
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABI-009Drug

    Also called nab-rapamycin

    rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)

Study groups in NCT03670030
Study groupRoleWhat they receive
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.
Receives: Drug: ABI-009

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Control Rate at 6 Months Per RECIST v1.1.

    Disease control rate at 6 months is the proportion of patients who have partial or complete response or stable disease at 6 months.

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 6 months

Secondary outcomes (1)

  1. Percent of Subjects Experiencing Adverse Events

    Percent of subjects with >=5% adverse events or grades 3 or 4 adverse events

    Measured: Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2018
  2. Study start5 Nov 2018
  3. Primary completion1 Jan 2021
  4. Study completion26 Feb 2021

Why it stopped: Slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670030
Sponsor's protocol ID
NET-001
Status last verified
May 2021
First submitted
12 Sep 2018
Last updated
10 Jun 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Only aggregate data will be made publicly available in the form of poster presentations or journal articles.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-009 in people with Neuroendocrine Tumors, run by Robert Ramirez at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate at 6 Months Per RECIST v1.1. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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