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NCT03298516 · ClinicalTrials.gov registry record · Phase 1
A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03298516 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 19 participants.
The verdict
NCT03298516, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This Phase Ia/Ib, open-label, multicenter study will evaluate the safety, tolerability, and preliminary efficacy of DCLL9718S as a single agent (Phase Ia, Arm A) in participants with relapsed or refractory AML or in combination with azacitidine (Phase Ib, Arm B) in participants with previously untreated AML who are not eligible for intensive induction chemotherapy. Each arm will consist of two stages: a dose-escalation stage and an expansion stage. The dose-escalation stage is designed to establish the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for DCLL9718S alone (Arm A) or in combination with azacitidine (Arm B). The dose-expansion stage is designed to characterize the long-term safety and tolerability of DCLL9718S.
Interventions
- DRUG Azacitidine
- DRUG DCLL9718S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03298516
The ClinicalTrials.gov registry entry for NCT03298516 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT03298516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03298516 about?
NCT03298516 is a clinical study titled "A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy". This Phase Ia/Ib, open-label, multicenter study will evaluate the safety, tolerability, and preliminary efficacy of DCLL9718S as a single agent (Phase Ia, Arm A) in participants with relapsed or refractory AML or in combination with azacitidine (Phase Ib, Arm B) in participants with previously untre...
What is the current status of trial NCT03298516?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2017-11-15. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03298516?
The interventions under investigation include: Azacitidine (DRUG), DCLL9718S (DRUG).
Who is sponsoring clinical trial NCT03298516?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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