Cancer - Acute Myeloid LeukemiaPhase 1NCT03484520
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing Venetoclax and Dinaciclib in people with Cancer - Acute Myeloid Leukemia, run by AbbVie at 13 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer - Acute Myeloid Leukemia
- What is being tested?
- Venetoclax and Dinaciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 23 Jul 2018to 1 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Who cannot join
- Known central nervous system leukemia
- Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
- Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
- History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
- Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States7 sites
University of Maryland School of Medicine /ID# 204015
Baltimore, Maryland, 21201-1544
The University ofChicago /ID# 200017
Chicago, Illinois, 60637
The Ohio State University /ID# 200668
Columbus, Ohio, 43210
University of Texas MD Anderson Cancer Center /ID# 205215
Houston, Texas, 77030
University of Arkansas /ID# 200016
Little Rock, Arkansas, 72205
David Geffen School of Medicin /ID# 200015
Los Angeles, California, 90095
Wake Forest Baptist Medical Center /ID# 200288
Winston-Salem, North Carolina, 27157-0001
Australia3 sites
Royal Hobart Hospital /ID# 202763
Hobart, Tasmania, 7000
Monash Medical Centre /ID# 202762
Melbourne, Victoria, 3168
Gold coast University Hospital /ID# 202759
Southport, Queensland, 4215
Spain3 sites
Hospital Universitario Ramon y Cajal /ID# 201729
Madrid, 28034
Hospital Universitario de Salamanca /ID# 201728
Salamanca, 37711
Hospital Universitario y Politecnico La Fe /ID# 202318
Valencia, 46026
About this study
Official title: Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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).
- Conditions
- Cancer - Acute Myeloid Leukemia
- Being tested
- Venetoclax, Dinaciclib
- Keywords
- Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib
- Medical subject headings
- Neoplasms, Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, GDC-0199
tablet, oral
DinaciclibDrug
Also called MK-7965, SCH-727965
intravenous
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax + Dinaciclib | Experimental | Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored. Receives: Drug: Venetoclax; Drug: Dinaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax of Venetoclax
Time to maximum plasma concentration (Tmax) of venetoclax.
Measured: Approximately 29 days after first dose of study drug
Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax
Tthe RPTD of co-administered venetoclax and dinaciclib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
Measured: Minimum first cycle of dosing (21 days)
Cmax of Venetoclax
Maximum observed plasma concentration (Cmax) for Venetoclax.
Measured: Approximately 29 days after first dose of study drug
AUCt of Venetoclax
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Measured: Approximately 29 days after first dose of study drug
AUC0-24 Post-dose of Venetoclax
Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
Measured: Approximately 29 days after first dose of study drug
Cmax of Dinaciclib
Maximum plasma concentration (Cmax) of dinaciclib.
Measured: Approximately 29 days after first dose of study drug
Half-life (t1/2) of Dinaciclib
Half-life (t1/2) of dinaciclib.
Measured: Approximately 29 days after first dose of study drug
AUCt Post-dose of Dinaciclib
Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib.
Measured: Approximately 29 days after first dose of study drug
AUC0-∞ of Dinaciclib
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of dinaciclib.
Measured: Approximately 29 days after first dose of study drug
Clearance of Dinaciclib
Clearance (CL) of dinaciclib.
Measured: Approximately 29 days after first dose of study drug
Secondary outcomes (3)
Complete Response (CR) Rate
CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
Measured: Up to approximately 18 months
Composite CR Rate (CR + CRi)
Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
Measured: Up to approximately 18 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on IWG criteria.
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start23 Jul 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer - Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484520
- Sponsor's protocol ID
- M16-183
- Other IDs
- 2017-003213-26, 2017
- Status last verified
- Dec 2022
- First submitted
- 26 Mar 2018
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03484520
- Acronym / sponsor ID
- M16-183
- Conditions
- Cancer - Acute Myeloid Leukemia
- Keywords
- Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax + Dinaciclib | Experimental | Drug: Venetoclax, Drug: DinaciclibVenetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Key exclusion criteria (7 listed)
- Known central nervous system leukemia
- Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
- Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
- History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: ABT-199, GDC-0199tablet, oral | Drug | Venetoclax + Dinaciclib |
| DinaciclibAlso: MK-7965, SCH-727965intravenous | Drug | Venetoclax + Dinaciclib |
Primary outcome
Tmax of Venetoclax
Time frame: Approximately 29 days after first dose of study drug
Time to maximum plasma concentration (Tmax) of venetoclax.
Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax
Time frame: Minimum first cycle of dosing (21 days)
Tthe RPTD of co-administered venetoclax and dinaciclib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
Cmax of Venetoclax
Time frame: Approximately 29 days after first dose of study drug
Maximum observed plasma concentration (Cmax) for Venetoclax.
AUCt of Venetoclax
Time frame: Approximately 29 days after first dose of study drug
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
AUC0-24 Post-dose of Venetoclax
Time frame: Approximately 29 days after first dose of study drug
Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
Cmax of Dinaciclib
Time frame: Approximately 29 days after first dose of study drug
Maximum plasma concentration (Cmax) of dinaciclib.
Half-life (t1/2) of Dinaciclib
Time frame: Approximately 29 days after first dose of study drug
Half-life (t1/2) of dinaciclib.
AUCt Post-dose of Dinaciclib
Time frame: Approximately 29 days after first dose of study drug
Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose dinaciclib.
AUC0-∞ of Dinaciclib
Time frame: Approximately 29 days after first dose of study drug
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of dinaciclib.
Clearance of Dinaciclib
Time frame: Approximately 29 days after first dose of study drug
Clearance (CL) of dinaciclib.
3 secondary outcomes
Complete Response (CR) Rate
Time frame: Up to approximately 18 months
Composite CR Rate (CR + CRi)
Time frame: Up to approximately 18 months
Objective Response Rate (ORR)
Time frame: Up to approximately 18 months
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax and Dinaciclib in people with Cancer - Acute Myeloid Leukemia, run by AbbVie at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax of Venetoclax (time frame: Approximately 29 days after first dose of study drug). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.