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NCT02152956 · ClinicalTrials.gov registry record · Phase 1
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by MacroGenics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 244
- Enrollment target
NCT02152956 is a Phase 1 study that was terminated before completion, run by MacroGenics. The registered enrollment target is 244 participants.
The verdict
NCT02152956, a Phase 1 study, was terminated before completion, sponsored by MacroGenics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 244 participants
- Enrollment target
Study Summary
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment. Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.
Interventions
- BIOLOGICAL Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
- BIOLOGICAL Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
- BIOLOGICAL Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
- BIOLOGICAL Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
- BIOLOGICAL Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2014-06-09 |
| Est. Completion | 2022-07-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02152956
The ClinicalTrials.gov registry entry for NCT02152956 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off is the first listed.
NCT02152956 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02152956 about?
NCT02152956 is a clinical study titled "Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)". Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed)....
What is the current status of trial NCT02152956?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2014-06-09. Estimated completion is 2022-07-05.
What interventions are being tested in trial NCT02152956?
The interventions under investigation include: Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off (BIOLOGICAL), Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off (BIOLOGICAL), Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off (BIOLOGICAL), Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off (BIOLOGICAL), Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT02152956?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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