Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01880437 · ClinicalTrials.gov registry record · Phase 2
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT01880437 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 38 participants.
The verdict
NCT01880437, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150 mg orally daily. In Cohort 2, patients will receive vismodegib 150 mg orally daily in combination with cytarabine 20 mg subcutaneously for 10 days. Anticipated time on study treatment is until disease progression, intolerable toxicity, or patient withdrawal of consent.
Interventions
- DRUG cytarabine
- DRUG vismodegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01880437
The ClinicalTrials.gov registry entry for NCT01880437 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which cytarabine is the first listed.
NCT01880437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01880437 about?
NCT01880437 is a clinical study titled "A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome". This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS). Patients in Cohort 1 will receive single-agent vismodegib 150 mg orally daily. In Cohort 2, patients wi...
What is the current status of trial NCT01880437?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2013-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01880437?
The interventions under investigation include: cytarabine (DRUG), vismodegib (DRUG).
Who is sponsoring clinical trial NCT01880437?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.