Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02587325 · ClinicalTrials.gov registry record · Phase 1
Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension
A Phase 1 study, sponsored by Aadi Bioscience.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02587325: Completed Phase 1 study, sponsored by Aadi Bioscience.
NCT02587325 is a Phase 1 study that has completed, run by Aadi Bioscience. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02587325, a Phase 1 study, has completed, sponsored by Aadi Bioscience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
mTOR activation has been shown to be relevant in the development and progression of pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension in animal models. nab-Sirolimus (also known as ABI-009, nab-rapamycin) is an albumin-bound mTOR inhibitor with improved penetration in lung tissue.
Primary Outcome
A dose-limiting toxicity (DLT) was defined as a study drug-related Grade ≥3 hematologic AE or persistent intolerable nonhematologic AE of any grade that occurred during the first 4 weeks of treatment, requiring dose reduction or permanent discontinuation of the study drug, in the opinion of the Investigator. The number and percent of patients with a DLT were to be reported by dose cohorts in the Phase 1 dose finding part of the study if any were observed in the study.
Interventions
- DRUG nab-sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2022-09-16 |
| Phase | Phase 1 |
What the finished NCT02587325 record still lists
NCT02587325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which nab-sirolimus is the first listed.
NCT02587325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02587325 about?
NCT02587325 is a clinical study titled "Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension". mTOR activation has been shown to be relevant in the development and progression of pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension in animal models. nab-Sirolimus (also known as ABI-009, nab-rapamycin) is an albumin-bound mTOR inhibitor with im...
What is the current status of trial NCT02587325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-04-01. Estimated completion is 2022-09-16.
What interventions are being tested in trial NCT02587325?
The interventions under investigation include: nab-sirolimus (DRUG).
Who is sponsoring clinical trial NCT02587325?
This trial is sponsored by Aadi Bioscience, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02587325's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI