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Cyclin-Dependent Kinase Inhibitor

Dinaciclib for Breast Cancer

Phase 1
Waitlist Available
Led By A. Jo Chien, MD
Research Sponsored by Jo Chien
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 3 years
Awards & highlights

Study Summary

This study is evaluating whether a drug called dinaciclib can be safely combined with a drug called pembrolizumab to treat breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Proportion of participants with reported dose-limiting toxicities (DLTs)
Secondary outcome measures
Overall Response Rate

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%
Nasal congestion
25%
Myalgia
25%
Hypoxia
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%
0%
Study treatment Arm
Dose Level I: Treatment (Ofatumumab, Dinaciclib)
Dose Level II: Treatment (Ofatumumab, Dinaciclib)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Dinaciclib, Pembrolizumab)Experimental Treatment2 Interventions
Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dinaciclib
Not yet FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,884 Previous Clinical Trials
5,054,354 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Jo ChienLead Sponsor
A. Jo Chien, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
266 Total Patients Enrolled
1 Trials studying Breast Cancer
266 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer
Jo Chien 2016. "Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01676753.
~4 spots leftby Apr 2025
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