A Study to testABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System
TerminatedPhase 2Results postedLast updated 10 June 2021
What this trial tests
Phase 2 trial testing ABI-009 in Neuroendocrine Tumors in 5 participants. Terminated before completion.
18 and older, any sex, with Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Disease Control Rate at 6 Months Per RECIST v1.1.Primary· 6 months
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.
Group
Value
95% CI
ABI-009
5
Percent of Subjects Experiencing Adverse EventsSecondary· Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months
Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Group
Value
95% CI
ABI-009
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03747328 — ABI-009 (Nab-sirolimus) in Patients With Genetically-confirmed Leigh or Leigh-like Syndrome
· Phase 2
· withdrawn
NCT03657420 — Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refra
· Phase 1
· withdrawn
NCT02009332 — Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
· Phase 1, PHASE2
· completed
NCT00635284 — ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies
· Phase 1
· completed
Other recruiting trials for Neuroendocrine Tumors
Currently open trials in the same condition.
NCT07404176 — Study to Assess the Safety and Effectiveness of Novel Radiopharmaceutical Terbium-161 DOTATATE in Metastatic Neuroendocr
· Phase 2
· recruiting
NCT07314164 — Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment
· recruiting
NCT07272512 — Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms
· Phase 4
· recruiting
NCT06735560 — Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, ICC or NEN
· NA
· recruiting
NCT06889493 — SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Dif
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Robert Ramirez
Last refreshed: 10 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03670030.