A Phase 1 interventional study of Venetoclax and Dinaciclib in Cancer - Acute Myeloid Leukemia, sponsored by AbbVie. Terminated at 13 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-30.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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).
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 48 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Compared within Leukemia, Myeloid, Acute, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
Drug: Venetoclax · Drug: Dinaciclib
tablet, oral
Also known as: ABT-199, GDC-0199
intravenous
Also known as: MK-7965, SCH-727965
Tmax of Venetoclax
Time to maximum plasma concentration (Tmax) of venetoclax.
Time frame: 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.
Time frame: Minimum first cycle of dosing (21 days)
Cmax of Venetoclax
Maximum observed plasma concentration (Cmax) for Venetoclax.
Time frame: 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)
Time frame: 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.
Time frame: Approximately 29 days after first dose of study drug
Cmax of Dinaciclib
Maximum plasma concentration (Cmax) of dinaciclib.
Time frame: Approximately 29 days after first dose of study drug
Half-life (t1/2) of Dinaciclib
Half-life (t1/2) of dinaciclib.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 29 days after first dose of study drug
Clearance of Dinaciclib
Clearance (CL) of dinaciclib.
Time frame: Approximately 29 days after first dose of study drug
Complete Response (CR) Rate
CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 18 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Dec 2022, 52 months.
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This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Venetoclax · Dinaciclib