FT-1101 News - LARVOL Sigma

||||||||||  FT-1101 / BMS, Novo Nordisk
Trial completion, Metastases:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Feb 1, 2022
P1b, N=24, Completed,  Sponsor: Celgene
Active, not recruiting --> Completed

||||||||||  FT-1101 / BMS, Novo Nordisk
Trial primary completion date, Metastases:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Aug 20, 2021
P1b, N=24, Active, not recruiting,  Sponsor: Celgene
Active, not recruiting --> Completed Trial primary completion date: Jul 2021 --> Oct 2021

||||||||||  FT-1101 / BMS, Novo Nordisk
Enrollment closed, Enrollment change, Metastases:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) -  May 17, 2021
P1b, N=24, Active, not recruiting,  Sponsor: Celgene
Trial primary completion date: Jul 2021 --> Oct 2021 Recruiting --> Active, not recruiting | N=40 --> 24

|||||||||| Clinical, Review, Journal: Safety and Efficacy of Bromodomain and Extra-Terminal Inhibitors for the Treatment of Hematological Malignancies and Solid Tumors: A Systematic Study of Clinical Trials. (Pubmed Central) - Feb 13, 2021
All BET inhibitors reviewed in our study exhibited exposure-dependent thrombocytopenia, which may limit their clinical application. Moreover, further efforts are necessary to explore the optimal dosing schemes and combinations to maximize the efficacy of BET inhibitors.

||||||||||  FT-1101 / BMS, Novo Nordisk
Trial completion date, Trial primary completion date, Metastases:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Jan 22, 2021
P1b, N=40, Recruiting,  Sponsor: Celgene
Moreover, further efforts are necessary to explore the optimal dosing schemes and combinations to maximize the efficacy of BET inhibitors. Trial completion date: Jun 2023 --> Jul 2021 | Trial primary completion date: Jun 2023 --> Jul 2021

||||||||||  FT-1101 / BMS, Novo Nordisk
Enrollment open, Metastases:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Dec 22, 2019
P1b, N=40, Recruiting,  Sponsor: Celgene
Trial completion date: Jun 2023 --> Jul 2021 | Trial primary completion date: Jun 2023 --> Jul 2021 Not yet recruiting --> Recruiting

|||||||||| azacitidine / Generic mfg., FT-1101 / Forma Therap, BMS
Phase 1 Dose Escalation and Expansion Study to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BET Inhibitor FT-1101 As a Single Agent in Patients with Relapsed or Refractory Hematologic Malignancies (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_5637;
P1
FT-1101, as monotherapy, shows acceptable safety, PK, and modest clinical activity in R/R AML/MDS and NHL pts. Intermittent (QOW) dosing within a tolerable range elicits PD activity (CCR1 suppression and HEXIM1 upregulation) consistent with preclinical observations indicating antitumor activity, and provides a rationale for testing FT-1101 in combination with standard therapies in AML/MDS and NHL.

||||||||||  FT-1101 / BMS, Novo Nordisk
Trial primary completion date, Metastases:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Oct 21, 2019
P1b, N=40, Not yet recruiting,  Sponsor: Celgene
Intermittent (QOW) dosing within a tolerable range elicits PD activity (CCR1 suppression and HEXIM1 upregulation) consistent with preclinical observations indicating antitumor activity, and provides a rationale for testing FT-1101 in combination with standard therapies in AML/MDS and NHL. Trial primary completion date: May 2021 --> Jun 2023

||||||||||  FT-1101 / BMS, Novo Nordisk
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) -  Jun 26, 2019
P1, N=94, Completed,  Sponsor: Forma Therapeutics, Inc.
Trial primary completion date: May 2021 --> Jun 2023 Recruiting --> Completed | N=160 --> 94 | Trial completion date: Oct 2019 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019

||||||||||  FT-1101 / BMS, Novo Nordisk
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) -  Feb 19, 2018
P1, N=160, Recruiting,  Sponsor: Forma Therapeutics, Inc.
Recruiting --> Completed | N=160 --> 94 | Trial completion date: Oct 2019 --> Mar 2019 | Trial primary completion date: Dec 2018 --> Mar 2019 N=78 --> 160 | Trial primary completion date: Feb 2018 --> Dec 2018 | Trial completion date: Aug 2018 --> Oct 2019

||||||||||  FT-1101 / BMS, Novo Nordisk
Enrollment open, Combination therapy:  Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) -  Oct 4, 2015
P1, N=78, Recruiting,  Sponsor: Forma Therapeutics, Inc.
N=78 --> 160 | Trial primary completion date: Feb 2018 --> Dec 2018 | Trial completion date: Aug 2018 --> Oct 2019 Not yet recruiting --> Recruiting

||||||||||  FT-1101 / BMS, Novo Nordisk
New P1 trial, Combination therapy:  Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov) -  Sep 8, 2015
P1, N=78, Not yet recruiting,  Sponsor: Forma Therapeutics, Inc.



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