Last reviewed · How we verify
Abemaciclib With or Without Atezolizumab for mCRPC
Phase 2 trial testing Abemaciclib in Prostate Cancer in 19 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 20 August 2021 |
| Primary completion | 17 June 2024 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across United States |
Dana-Farber Cancer Institute
18 and older, male only, with Prostate Cancer or Metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of participants alive and progression-free at 6 months, as assessed by RECIST 1.1 and PCWG3.
| Group | Value | 95% CI |
|---|---|---|
| Biomarker-Unselected Abemaciclib Monotherapy (Randomized) | 100 | 100 – 100 |
| Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) | NA | NA – NA |
| CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) | 50 | 10 – 81 |
The percentage of evaluable patients who had radiographic response (complete response or partial response) by RECIST 1.1 criteria OR 50% decline in PSA from pretreatment baseline per PCWG3 criteria.
| Group | Value | 95% CI |
|---|---|---|
| Biomarker-Unselected Abemaciclib Monotherapy (Randomized) | 0 | 0 – 0 |
| Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) | 12.5 | 0.6 – 47 |
| CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) | 0 | 0 – 0 |
DLT was assessed by Bayesian Continuous Toxicity Monitoring in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms.
| Group | Value | 95% CI |
|---|---|---|
| Biomarker-Unselected Abemaciclib Monotherapy (Randomized) | 0 | |
| Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) | 4 | |
| CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) | 0 | |
| CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) | 0 |
The percentage of participants who are alive 12 months after the start of treatment
| Group | Value | 95% CI |
|---|---|---|
| Biomarker-Unselected Abemaciclib Monotherapy (Randomized) | 83 | 39 – 97 |
| Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) | 50 | 20 – 74 |
| CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized) | 75 | 22 – 95 |
Time frame: From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Biomarker-Unselected Abema… | Biomarker-Unselected Abema… | CDK12 Mutation Atezolizuma… | CDK12 Mutation Abemaciclib… |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Hepatic failure | Hepatobiliary disorders | — | — | — | — |
| Joint infection | Infections and infestations | — | — | — | — |
| Skin infection | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Stroke | Nervous system disorders | — | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Biomarker-Unselected Abema… | Biomarker-Unselected Abema… | CDK12 Mutation Atezolizuma… | CDK12 Mutation Abemaciclib… |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders and administration site conditions | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Fever | General disorders and administration site conditions | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Edema limbs | General disorders and administration site conditions | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Weight loss | Investigations | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Obesity | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Urinary frequency | Renal and urinary disorders | — | — | — | — |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hot flashes | Vascular disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Cardiac disorders - Other, specify | Cardiac disorders | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — |
| Hyperthyroidism | Endocrine disorders | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — | — |
Most-reported serious reactions: Sepsis, Anemia, Atrial fibrillation, Abdominal pain, Small intestinal obstruction, Hepatic failure, Joint infection, Skin infection.
Data from ClinicalTrials.gov NCT04751929 adverse events section.
This trial is testing whether a molecularly targeted chemotherapy drug called abemaciclib and an immunotherapy drug called atezolizumab, alone or in combination, are effective in shrinking or preventing the growth of metastatic prostate cancer. The trial is also testing the safety of the combination of abemaciclib with atezolizumab.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04751929.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing