Compilation of BET inhibitor Trials
posted on
Oct 05, 2017 01:13PM
After imtesty posted this paper, I was inspired to put together a compilation of ongoing, completed, terminated or withdrawn BET inhibitor trials that are listed on ClinicalTrials.gov.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 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