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Eugene A Woltering



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    EP1.12 - Small Cell Lung Cancer/NET (ID 202)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-18 - NET-001: A Phase II Study of ABI-009 in Metastatic Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System (Now Available) (ID 1391)

      08:00 - 18:00  |  Author(s): Eugene A Woltering

      • Abstract
      • Slides

      Background

      Neuroendocrine tumors (NETs) are a heterogeneous group of malignancies with limited systemic treatment options. Preclinical evidence has shown that the PI3K/AKT/mTOR signaling pathway plays a central role in the pathogenesis and progression of NETs. Clinical studies with the mTOR inhibitor, everolimus, demonstrated its safety and efficacy in the treatment of NET, however, patients will ultimately progress. A novel mTOR inhibitor, ABI-009 (albumin-bound rapamycin nanoparticles, nab-rapamycin), has a favorable safety profile and evidence of efficacy in patients with solid tumors and offers promise for NETs. A preclinical study showed significantly greater antitumor activity and prolonged survival with ABI-009 compared with equal weekly dosing of oral rapamycin and oral everolimus. This preclinical study demonstrated superior efficacy of ABI-009 to oral mTOR inhibitors and suggest that ABI-009 may result in disease control after everolimus failure. The goal of this phase II pilot study is to evaluate the utility of ABI-009 in NETs to warrant a full phase II clinical study.

      Method

      This pilot phase II trial is a prospective, open-label, single arm, single center trial evaluating the efficacy and safety of ABI-009 in patients with gastroenteropancreatic or lung NETs who have undergone prior treatment with everolimus. Patients with unresectable, metastatic grade 1 and 2 NETs of the gastroenteropancreatic system or lung who have progressed or have been intolerant to everolimus will be eligible for inclusion in this study. The study will enroll 10 patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. ABI-009 will be administered intravenously at 100 mg/m2 on days 1 and 8 of a 21-day cycle. Patients will be treated until disease progression. Tumor response will be assessed by computerized tomography scan at baseline then every 9 weeks for 1 year, then every 12 weeks thereafter until progression. The primary endpoint is disease control rate at 6 months measured by RECIST 1.1. Currently, 3 of the planned 10 patients have been enrolled. ClinicalTrials.gov Identifier: NCT03670030.

      Result

      Section not applicable

      Conclusion

      Section not applicable

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