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CFI-400945

DRUG6 trials

Sponsors

University Health Network, Toronto, Canadian Cancer Trials Group, Treadwell Therapeutics, Inc

Conditions

AMLAcute Myeloid LeukemiaAdvanced CancerBreast CancerCMMLChronic Myelomonocytic LeukemiaMDSMyelodysplastic Syndromes

Phase 1

A Study of CFI-400945 Fumarate in Patients With Advanced Cancer
CompletedNCT01954316
University Health Network, TorontoAdvanced Cancer
Start: 2014-03-31End: 2021-07-22Updated: 2024-01-17
A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML
Active, not recruitingNCT04730258
Treadwell Therapeutics, IncAcute Myeloid Leukemia, AML, Chronic Myelomonocytic Leukemia +3
Start: 2021-04-16End: 2026-01-31Target: 72Updated: 2025-05-18

Phase 2

Prostate Cancer Biomarker Enrichment and Treatment Selection
Active, not recruitingNCT03385655
Canadian Cancer Trials GroupProstate Cancer
Start: 2018-08-01End: 2025-12-31Updated: 2025-08-21
CFI-400945 in Patients With Advanced/Metastatic Breast Cancer
Active, not recruitingNCT03624543
Canadian Cancer Trials GroupBreast Cancer
Start: 2019-02-14End: 2026-12-31Updated: 2026-01-30
CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer
Active, not recruitingNCT04176848
Canadian Cancer Trials GroupBreast Cancer
Start: 2020-08-10End: 2026-12-31Updated: 2026-02-18
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
RecruitingNCT05601440
Canadian Cancer Trials GroupBreast Cancer
Start: 2023-06-13End: 2028-06-30Target: 484Updated: 2026-03-27

Related Papers

Substudy G of the Canadian cancer trials group (CCTG) IND.234: PC_BETS (V)—A circulating tumor DNA (ctDNA)–directed phase II study of carboplatin in patients (Pts) with previously treated metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2025-05-282 citations
IND.241: A Canadian Cancer Trials Group liquid-biopsy informed platform trial to evaluate treatment in CDK4/6-inhibitor resistant ER+/HER2- metastatic breast.
Journal of Clinical Oncology2025-05-281 citations
Canadian Cancer Trials Group (CCTG) IND.234/223: PC_BETS (Prostate Cancer Biomarker Enrichment and Treatment Selection)–A molecularly selected cooperative group platform study.
Journal of Clinical Oncology2025-05-28
Substudy C of the Canadian cancer trials group (CCTG) IND.234: PC_BETS (Prostate Cancer Biomarker Enrichment and Treatment Selection)—A phase II study of darolutamide (DARO) selected by androgen-receptor (AR) circulating tumor DNA (ctDNA) in patients (PTS) with metastatic castration-resistant prostate cancer (mCRPC) after prior AR pathway inhibitors (ARPIs).
Journal of Clinical Oncology2025-05-28
Substudy F of the Canadian Cancer Trials Group (CCTG) IND.234: PC_BETS (Prostate Cancer Biomarker Enrichment and Treatment Selection)—A biomarker-selected phase II study of durvalumab and tremelilumab (DT) in patients (pts) with previously treated metastatic castration-resistant prostate cancer (mCRPC) resistant to AR pathway inhibitors (ARPI).
Journal of Clinical Oncology2025-05-28
Preclinical characterization and clinical trial of CFI-400945, a polo-like kinase 4 inhibitor, in patients with relapsed/refractory acute myeloid leukemia and higher-risk myelodysplastic neoplasms.
2023-12-1915 citations
Preliminary Results from a Phase 1b/2 Open-Label, Multicenter, Dose Optimization Clinical Study of the Safety, Tolerability, and Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of Cfi-400945 As a Single Agent or in Combination with Azacitidine in Patients (Pts) with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (TWT-202)
Blood2023-11-02
Abstract P3-07-14: A phase II study of CFI-400945 in patients with advanced/metastatic cancer: Canadian Cancer Trials Group (CCTG) IND.237
Cancer Research2023-03-011 citations
Prospective ctDNA genotyping for treatment selection in metastatic castration-resistant prostate cancer (mCRPC): The Canadian Cancer Trials Group phase II PC-BETS umbrella study.
Journal of Clinical Oncology2023-02-205 citations
Preliminary Results from a Phase 2 Open-Label, Multicenter, Dose Optimization Clinical Study of the Safety, Tolerability, and Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of Cfi-400945 As a Single Agent or in Combination with Azacitidine or Decitabine in Patients with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (TWT-202)
Blood2022-11-154 citations
Polyploidy Is Necessary for Apoptotic Cell Death in <i>TP53</i>-Mut AML in Response to Polo-like-Kinase 4 (PLK4) Inhibition and Results in Caspase 3 Cleavage
Blood2022-11-152 citations
Targeting Polo-like Kinase 4 Triggers Polyploidy and Apoptotic Cell Death in TP53-Mutant Acute Myeloid Leukemia
Blood2021-11-055 citations
The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer.
2020-06-2623 citations
Prostate cancer biomarker enrichment and treatment selection (PC-BETS) study: A Canadian cancer trials group phase II umbrella trial for metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2020-05-2012 citations
Safety and tolerability of CFI-400945, a first-in-class, selective PLK4 inhibitor in advanced solid tumours: a phase 1 dose-escalation trial
British Journal of Cancer2019-07-1466 citations
Abstract 1948: Polo-like kinase 4 inhibition produces polyploidy and apoptotic death of lung cancers
Cancer Research2018-07-012 citations