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

NCT03670030 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: NET-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (1)

• Percent of Subjects Experiencing Adverse Events

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

Study Arms (1)

ABI-009

EXPERIMENTAL

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

Interventions

ABI-009 DRUG

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

Also known as: nab-rapamycin

ABI-009

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• a. 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Robert Ramirez: lead
• Aadi Bioscience, Inc.: collaborator

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Limitations and Caveats

Early termination leading to small numbers affecting usefulness interpreting results. Only 2 patients were eligible for analysis of primary outcome.

Results Point of Contact

• Title: Robert Ramirez, DO
• Organization: Ochsner Medical Center

awendt@ochsner.org

504-464-8500

Study Officials

• Robert Ramirez, DO

  Ochnser Clinic Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 13, 2018
• Study Start: November 5, 2018
• Primary Completion: January 1, 2021
• Study Completion: February 26, 2021
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)