A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- AbbVie
- Study ID
- NCT03484520
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Cancer - Acute Myeloid Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax — DRUGtablet, oral
- Dinaciclib — DRUGintravenous
Study Details
An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).
Key Dates
- First listed
- Mar 30, 2018
- Start date
- Jul 23, 2018
- Status verified
- Dec 2022
- Primary completion
- Dec 1, 2022
- Completion
- Dec 1, 2022
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Venetoclax + DinaciclibVenetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
Primary Outcome Measure
Tmax of Venetoclax [ Time Frame: Approximately 29 days after first dose of study drug ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arkansas /ID# 200016 | Little Rock | Arkansas | 72205 | - |
| David Geffen School of Medicin /ID# 200015 | Los Angeles | California | 90095 | - |
| The University ofChicago /ID# 200017 | Chicago | Illinois | 60637 | - |
| University of Maryland School of Medicine /ID# 204015 | Baltimore | Maryland | 21201-1544 | - |
| Wake Forest Baptist Medical Center /ID# 200288 | Winston-Salem | North Carolina | 27157-0001 | - |
| The Ohio State University /ID# 200668 | Columbus | Ohio | 43210 | - |
| University of Texas MD Anderson Cancer Center /ID# 205215 | Houston | Texas | 77030 | - |