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CDK Inhibitor

Dinaciclib for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 18 months

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat leukemia. The goal is to find the best dose of the drugs and to see if they are safe and work well together.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC0-24 Post-dose of Venetoclax

AUC0-∞ of Dinaciclib

AUCt Post-dose of Dinaciclib

+7 more

Secondary outcome measures

Complete Response (CR) Rate

Composite CR Rate (CR + CRi)

Objective Response Rate (ORR)

Side effects data

From 2016 Phase 1 & 2 trial • 36 Patients • NCT01515176

100%

Neutrophil Count Decreased

100%

Platelet Count Decreased

100%

Hyperglycemia

75%

Anemia

75%

Pain

75%

Hypoalbuminemia

75%

Hypocalcemia

50%

Alanine Aminotransferase Increased

50%

Vomiting

50%

Fatigue

50%

Lymphocyte Count Decreased

50%

Lymphocyte Count Increased

50%

White Blood Cell Decreased

50%

Hypokalemia

50%

Hypomagnesemia

50%

Paresthesia

50%

Peripheral sensory neuropathy

50%

Aspartate Aminotransferase Increased

50%

Cough

25%

Hypoxia

25%

Nasal congestion

25%

Myalgia

25%

Pain in Extremity

25%

Headache

25%

General Disorders and Administration site Conditions-other

25%

Blood Bilirubin Decreased

25%

Ankle Fracture

25%

Hypermagnesemia

25%

LEUKOCYTOSIS

25%

PLEURAL INFECTION

25%

LYMPHOCYTE COUNT DECREASED

25%

Abdominal pain

25%

Constipation

25%

Diarrhea

25%

Chills

25%

Fever

25%

Fracture

25%

Hyponatremia

25%

Hypophosphatemia

25%

Proteinuria

25%

Hyperhidrosis

25%

Nausea

25%

Bruising

25%

Musculoskeletal and connective tissue disorder

100%

80%

60%

40%

20%

Study treatment Arm

Dose Level I: Treatment (Ofatumumab, Dinaciclib)

Dose Level II: Treatment (Ofatumumab, Dinaciclib)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venetoclax + DinaciclibExperimental Treatment2 Interventions

Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Dinaciclib

2012

Completed Phase 3

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,499 Total Patients Enrolled

AbbVieLead Sponsor

954 Previous Clinical Trials

500,996 Total Patients Enrolled

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

101,509 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research sites have been approved to conduct this trial?

"This trial is recruiting from 12 different locations, including The University of Chicago/ID# 200017 in Chicago, Illinois; The Ohio State University /ID#200668 in Columbus, Ohio; and the University ofChicago /ID#200017 in Winston-Salem, North carolina."

Answered by AI

Has Dinaciclib been investigated in other research studies?

"In 2009, Dinaciclib was first tested at Clinton Memorial Hospital and since then 62 trials have been concluded. Currently, 221 studies are still running with the majority of them operating in Chicago, Illinois."

Answered by AI

What is the capacity of this research endeavor in terms of participant numbers?

"Unfortunately, this clinical trial is not in the process of enrolling any patients at present. The initial posting for the study occurred on July 23rd 2018 and it was last updated on September 15th 2022. If you're looking to participate in another medical study, there are currently 1534 trials recruiting participants with leukemia or myeloid diseases and 221 studies admitting individuals desiring Dinaciclib treatments."

Answered by AI

What potential hazards have been associated with Dinaciclib treatment?

"A score of 1 was attributed to Dinaciclib, as Phase 1 trials typically provide only preliminary safety and efficacy data."

Answered by AI

Are there still open spots for enrolment in this trial?

"According to clinicaltrials.gov, this trial is no longer seeking applicants as the last time it was modified was September 15th 2022. Nevertheless, there are still 1755 other studies that require volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

2018. "A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03484520.