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CDK4/6 Inhibitor

Abemaciclib +/− Atezolizumab for Prostate Cancer

Phase 2

Waitlist Available

Led By Atish Choudhury, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Participants must have adequate organ and marrow function as defined below: leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL hemoglobin ≥9 g/dL (without transfusion or growth factor in prior 28 days) platelets ≥100,000/mcL (without transfusion or growth factor in prior 28 days) total bilirubin ≤1.5 × institutional upper limit of normal, unless the subject has known or suspected Gilbert's syndrome AST(SGOT)/ALT(SGPT) ≤1.5 × institutional upper limit of normal creatinine clearance ≥30 mL/min/1.73 m2 Life expectancy of at least 6 months, as determined by a study Investigator. Ability to swallow oral medications. Ability to understand and willingness to sign an IRB-approved informed consent.

Patients with ≤ CTCAE grade 2 anorexia, alopecia, neuropathy, and/or fatigue however, are also permitted to enroll.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to end of treatment, up to 2 years

Awards & highlights

Study Summary

This trial is testing the effectiveness of a molecularly targeted chemotherapy drug and an immunotherapy drug in shrinking or preventing the growth of metastatic prostate cancer.

Who is the study for?

This trial is for adult males with metastatic castration-resistant prostate cancer (mCRPC) who have progressive disease and are not candidates for certain chemotherapies. They must have tried at least one antiandrogen therapy, maintain low testosterone levels, and be in good enough health to participate. Men with untreated brain metastases or active autoimmune diseases treated recently are excluded.Check my eligibility

What is being tested?

The trial examines the effectiveness of abemaciclib alone or combined with atezolizumab in treating mCRPC. It also assesses the safety of this combination therapy. Participants will receive molecularly targeted chemotherapy and immunotherapy drugs to see if they can shrink or halt tumor growth.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues, blood-related problems, increased risk of infections, and possibly others specific to each drug's profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild symptoms like loss of appetite, hair loss, nerve pain, or tiredness.

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My cancer has spread, and it can be measured by a blood test or scans.

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I cannot take taxane due to health reasons.

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I am maintaining low testosterone levels for my treatment.

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I am maintaining low testosterone levels for my treatment.

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I have recovered from side effects of previous treatments.

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I am a man aged 18 or older.

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My cancer has a CDK12 loss of function, confirmed by a specific genetic test.

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I can take pills by mouth.

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My cancer has spread, and it can be checked by scans or biopsy.

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My tests show a CDK12 loss in my cancer's genetic material.

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I have advanced prostate cancer that is not responding to hormone therapy.

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I have tried at least one advanced prostate cancer treatment and it didn't work or caused side effects.

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My cancer has grown or spread, confirmed by scans.

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I am an adult male with advanced prostate cancer that is getting worse.

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My condition worsened within 12 months after finishing or not tolerating a taxane treatment.

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I cannot receive docetaxel or cabazitaxel chemotherapy.

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I have refused taxane treatment.

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I am fully active or can carry out light work.

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I cannot receive docetaxel or cabazitaxel due to past issues or my doctor's advice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of treatment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to end of treatment, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment, up to 2 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

6-month Progression free survival (PFS) rate

Objective response rate (ORR)

Rate of Adverse Events

+1 more

Secondary outcome measures

Clinical benefit rate (CBR)

Duration of response (DOR)

Duration of therapy (DOT)

+2 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Trial Design

4Treatment groups

Experimental Treatment

Group I: CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)Experimental Treatment1 Intervention

Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment. Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle

Group II: CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)Experimental Treatment2 Interventions

Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment. Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle

Group III: Biomarker-Unselected Abemaciclib Monotherapy (Randomized)Experimental Treatment1 Intervention

Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab Monotherapy : Participants will receive Abemaciclib orally 2x daily

Group IV: Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)Experimental Treatment2 Interventions

Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

FDA approved

Atezolizumab

FDA approved

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,873 Total Patients Enrolled

76 Trials studying Prostate Cancer

16,030 Patients Enrolled for Prostate Cancer

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,200,983 Total Patients Enrolled

14 Trials studying Prostate Cancer

1,941 Patients Enrolled for Prostate Cancer

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,614 Total Patients Enrolled

16 Trials studying Prostate Cancer

6,135 Patients Enrolled for Prostate Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04751929 — Phase 2

Prostate Cancer Research Study Groups: CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized), CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized), Biomarker-Unselected Abemaciclib Monotherapy (Randomized), Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)

Prostate Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04751929 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04751929 — Phase 2

Frequently Asked Questions

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

What is the mortality rate of Abemaciclib?

"Abemaciclib falls into Phase 2 of clinical trials, so there is some evidence suggesting it is safe but not yet effective."

Answered by AI

Are patients being enrolled in this trial at this time?

"Yes, the information on clinicaltrials.gov points out that this trial is actively searching for patients. The trial was initially posted on 8/20/2021 and was most recently edited on 9/26/2022. The study is looking for 75 patients at 1 sites."

Answered by AI

What has Abemaciclib been shown to be an effective treatment for?

"Abemaciclib has shown to be effective in treating small cell lung cancer (sclc), advanced hr + her2 - breast cancer, and malignant neoplasms."

Answered by AI

Is this an experimental medical study?

"Abemaciclib has been the focus of clinical research for over a decade. In 2008, Hoffmann-La Roche conducted the first study which resulted in Abemaciclib receiving Phase 2 drug approval. As of now, there are 447 live studies being conducted in 74 different countries and 2133 cities."

Answered by AI

What goals does this experiment hope to realize?

"The primary metric for success in this clinical trial, which will follow patients from enrollment to 6 months post-enrollment, is the Rate of Dose Limiting Toxicity (DLT). Additionally, researchers will also track Duration of response (DOR), defined as Assessed by RECIST1.1 and by PCWG3, Duration of therapy (DOT), defined as Assessed by RECIST1.1 and by PCWG3, and Clinical benefit rate (CBR), defined as Assessed by RECIST1.1, PCWG3 and PSA."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Abemaciclib With or Without Atezolizumab for mCRPC

Atish Choudhury, MD 2021. "Abemaciclib With or Without Atezolizumab for mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04751929.

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