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NCT02575963 · ClinicalTrials.gov registry record · Phase 1
Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
A Phase 1 study, sponsored by Actinium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02575963: Completed Phase 1 study, sponsored by Actinium Pharmaceuticals.
NCT02575963 is a Phase 1 study that has completed, run by Actinium Pharmaceuticals. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02575963, a Phase 1 study, has completed, sponsored by Actinium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The study is a multicenter, open label Phase I/II trial. 1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion) 2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225 alone (Phase 2 portion)
Primary Outcome
If two or more patients in a cohort experience dose limiting toxicity (DLT), then maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. If only three patients were treated at a dose level under consideration as the MTD, then up to three additional patients will be accrued. If no more than one of the six patients at that dose level experiences DLT, then that dose level will be confirmed as the MTD.
Interventions
- DRUG Spironolactone
- DRUG Cytarabine (Phase 1 only)
- BIOLOGICAL Lintuzumab-Ac225
- DRUG Furosemide (Phase 1 only)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-10 |
| Est. Completion | 2020-05 |
| Phase | Phase 1 |
What the finished NCT02575963 record still lists
NCT02575963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Spironolactone is the first listed.
NCT02575963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02575963 about?
NCT02575963 is a clinical study titled "Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients". The study is a multicenter, open label Phase I/II trial. 1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion) 2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac22...
What is the current status of trial NCT02575963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-10. Estimated completion is 2020-05.
What interventions are being tested in trial NCT02575963?
The interventions under investigation include: Spironolactone (DRUG), Cytarabine (Phase 1 only) (DRUG), Lintuzumab-Ac225 (BIOLOGICAL), Furosemide (Phase 1 only) (DRUG).
Who is sponsoring clinical trial NCT02575963?
This trial is sponsored by Actinium Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02575963's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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
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