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Message: Compilation of BET inhibitor Trials

After imtesty posted this paper, I was inspired to put together a compilation of ongoing, completed, terminated or withdrawn BET inhibitor trials that are listed on ClinicalTrials.gov. I may have missed some, but this should be close to a complete list of all past and current BET inhibitor trials. The dates that are listed as (date 1/date 2) indicated what is listed on ClincalTrials.gov for Estimated Primary Completion Date/Estimated Study Completion Date. It looks like 2018 should be an exciting year for lots of ongoing trials to be completed. ALL trials with the exception of Resverlogix are in the cancer area. 

Enjoy!

BearDownAZ

 

Resverlogix RVX-208/Apabetalone

Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD (BETonMACE)

https://clinicaltrials.gov/ct2/show/NCT02586155

https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002040-14/NL

Phase 3; September 2018/October 2018

 

Safety and Effect of Oral RVX000222 in Subjects With Fabry Disease

https://clinicaltrials.gov/ct2/show/NCT03228940

Phase1/2; October 2018/November 2018

 

A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis

https://clinicaltrials.gov/ct2/show/NCT03160430

Phase 1/2a; July 2018/July 2018

 

A Phase I, Open-Label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of a Single Oral Dose of RVX000222 in Subjects with Severe Renal Impairment.

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370605&isReview=true

Phase 1 New Zealand Trial; Completed

 

Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol

https://clinicaltrials.gov/ct2/show/NCT00768274

Phase 1; Completed

 

The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes

https://clinicaltrials.gov/ct2/show/NCT01728467

Phase 2; Completed

 

The Study of Quantitative Serial Trends in Lipids With ApolpoproteinA-I Stimulation (SUSTAIN)

https://clinicaltrials.gov/ct2/show/NCT01423188

Phase 2; Completed

 

ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation (ASSURE I)

https://clinicaltrials.gov/ct2/show/NCT01067820

https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-023801-36/BE

Phase 2; Completed

 

Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease (ASSERT)

https://clinicaltrials.gov/ct2/show/NCT01058018

Phase 2; Completed

 

Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia

https://clinicaltrials.gov/ct2/show/NCT01863225

Phase 2; Terminated

 

Zenith ZEN-3694 and ZEN-3365

 A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer

https://clinicaltrials.gov/ct2/show/NCT02705469

Phase 1; April 2018/April 2018

 

A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

https://clinicaltrials.gov/ct2/show/NCT02711956

Phase 1; April 2018/April 2018

 

Phase 1 Study Evaluating ZEN003365 in Relapsed/Refractory Lymphoproliferative Malignancies or Relapsed/Refractory AML

https://clinicaltrials.gov/ct2/show/NCT02238522

Phase 1; Withdrawn

 

  

GS-5829

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 in Adults With Advanced Solid Tumors and Lymphomas

https://clinicaltrials.gov/ct2/show/NCT02392611

Phase 1; December 2018/December 2018

 

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer

https://clinicaltrials.gov/ct2/show/NCT02607228

Phase 1/2; May 2019/October 2019

 

GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer

https://clinicaltrials.gov/ct2/show/NCT02983604

Phase 1/2; March 2019/February 2021

 

 

CPI-0610

 A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma

https://clinicaltrials.gov/ct2/show/NCT01949883

Phase 1; April 2018/July 2018

 

A Phase 1 Study Evaluating CPI-0610 in Patients With Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis

https://clinicaltrials.gov/ct2/show/NCT02158858

Phase 1; October 2018/January 2019

 

A Phase 1 Study Evaluating CPI-0610 in Patients With Previously Treated Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT02157636

Phase 1; December 2018/March 2019

 

Study of CPI-0610 in Patients With Malignant Peripheral Nerve Sheath Tumors

https://clinicaltrials.gov/ct2/show/NCT02986919

Phase 2; March 2019/March 2020

 

 

R06870810/TEN-010

A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies

https://clinicaltrials.gov/ct2/show/NCT01987362

Phase 1; December 2017/December 2017

 

A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome

https://clinicaltrials.gov/ct2/show/NCT02308761

Phase 1; January 2018/April 2018

 

Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT03068351

Phase 1; January 2020/January 2020

 

 

MK-8628/OTX015

A Dose Exploration Study With MK-8628 in Participants With Selected Hematologic Malignancies (MK-8628-005)

https://clinicaltrials.gov/ct2/show/NCT02698189

Phase 1; November 2017/November 2017

 

A Phase IB Dose Exploration Trial with MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects with Selected Advanced Solid Tumors

https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005488-18/FR

Phase 1b trial listed on EU Clinical Trials Register (may be completed and same as ClinicalTrials.gov trial)

 

A Dose-Finding Study of OTX105/MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)

https://clinicaltrials.gov/ct2/show/NCT02259114

Phase 1; Completed

 

A Phase I, Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/MK-8628 in Hematologic Malignancies (MK-8628-001)

https://clinicaltrials.gov/ct2/show/NCT01713582

Phase 1; Completed

 

A Dose Exploration Study With MK-8628 in Participants With Selected Advanced Solid Tumors (MK-8628-006)

https://clinicaltrials.gov/ct2/show/NCT02698176

Phase 1; Terminated

 

A Trial With Dose Optimization of OTX015 in Recurrent Glioblastoma Multiforme (GBM) Patients (OTX015_107)

https://clinicaltrials.gov/ct2/show/NCT02296476

Phase 1/2; Terminated

 

A Study Assessing tOTX015 in Combination With Azacitidine (AZA) or AZA Single Agent in Patients With Newly-diagnosed Acute Myeloid Leukemia (AML) Not Candidate for Standard Intensive Induction Therapy (SIIT)

https://clinicaltrials.gov/ct2/show/NCT02303782

Phase 1/2; Withdrawn

 

 

GSK2820151 and GSK525762

Dose Escalation Study of GSK2820151 in Subjects With Advanced or Recurrent Solid Tumors

https://clinicaltrials.gov/ct2/show/NCT02630251

Phase 1; May 2019/May 2019

 

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers

https://clinicaltrials.gov/ct2/show/NCT01587703

Phase 1 (possibly I/II); March 2019/September 2019

 

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies

https://clinicaltrials.gov/ct2/show/NCT01943851

Phase 1; February 2018/February 2020

 

A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with relapsed, refractory
hematologic malignancies

https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000445-39/GB

Phase 1/2 on EU Clinical Trials Register (may be same as ClinicalTrials.gov trial)

 

Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Subjects With Estrogen Receptor Positive (ER+) Breast Cancer

https://clinicaltrials.gov/ct2/show/NCT02964507

Phase 2; November 2019/June 2020

 

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors

https://clinicaltrials.gov/ct2/show/NCT03266159

Phase 2; August 2020/August 2020

 

A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential

https://clinicaltrials.gov/ct2/show/NCT02706535

Phase 1; Completed

 

  

INCB054329 and INCB057643

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

https://clinicaltrials.gov/ct2/show/NCT02431260

Phase 1/2; October 2017/February 2018

 

A Phase 1/2, Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

https://clinicaltrials.gov/ct2/show/NCT02711137

Phase 1/2; June 2018/July 2018

 

 

Other

A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

https://clinicaltrials.gov/ct2/show/NCT02391480

Phase 1; May 2018/August 2018

 

Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies

https://clinicaltrials.gov/ct2/show/NCT02543879

Phase 1; February 2018/August 2018

 

Study of BMS-986158 in Subjects With Select Advanced Solid Tumors (BET)

https://clinicaltrials.gov/ct2/show/NCT02419417

Phase 1/2; December 2018/December 2018

 

A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and
Extra-Terminal (BET) Proteins, in Subjects with Selected Advanced Solid Tumors

https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000324-29/GB

Phase ½ from EU Clinical Trials Register (may be same as ClinicalTrials.gov trial)

 

NMP in Relapsed / Refractory Myeloma

https://clinicaltrials.gov/ct2/show/NCT02468687

Phase 1; January 2017/February 2019

 

BI 894999 First in Human Dose Finding Study in Advanced Malignancies

https://clinicaltrials.gov/ct2/show/NCT02516553

Phase 1; October 2017/February 2019

 

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas

https://clinicaltrials.gov/ct2/show/NCT03220347

Phase 1; May 2020/April 2022

 

A Study of Single Agent SF1126 Inhibitor in Patients With Advanced Hepatocellular Carcinoma (SRX)

https://clinicaltrials.gov/ct2/show/NCT03059147

Phase 1; October 2022/October 2022

 

BAY1238097, First in Man

https://clinicaltrials.gov/ct2/show/NCT02369029

Phase 1; Terminated

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