- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date, Trial primary completion date, Monotherapy: Itacitinib for Low Risk GVHD (clinicaltrials.gov) - Nov 6, 2020 P2, N=70, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Dec 2020 --> Apr 2021
- |||||||||| itacitinib (INCB039110) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] A Single-Arm, Open-Label Phase 1 Study of Itacitinib (ITA) with Calcineurin Inhibitor (CNI)–Based Interventions for Prophylaxis of Graft-Versus-Host Disease (GVHD; GRAVITAS-119) (Channel 23 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3082; P1 Pts received oral ITA 200 mg once daily (QD) beginning 3 d before HCT + tacrolimus (Tac)/methotrexate (MTX) or cyclosporine A (CSA)/mycophenolate mofetil (MMF) ± antithymocyte globulin (ATG) per institutional practice...Busulfan/fludarabine (51%) and a fludarabine/melphalan reduced-intensity regimen (18%) were the most common conditioning regimens; 11% of regimens contained total body irradiation...8 pts in the +ATG group received post-transplant rituximab for EBV infection (n=7) and/or azaciditine maintenance therapy (n=3)...1 pt with MF did not achieve ANC recovery on Day 28. An ITA + Tac + post-transplant cyclophosphamide cohort is currently being investigated in GRAVITAS-119.
- |||||||||| itacitinib (INCB039110) / Incyte
Phase classification, Enrollment change, Trial completion date, Trial primary completion date: GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - Oct 28, 2020 P2/3, N=401, Recruiting, An ITA + Tac + post-transplant cyclophosphamide cohort is currently being investigated in GRAVITAS-119. Phase classification: P3 --> P2/3 | N=266 --> 401 | Trial completion date: Oct 2023 --> Feb 2025 | Trial primary completion date: Aug 2023 --> Jan 2024
- |||||||||| itacitinib (INCB039110) / Incyte
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease (clinicaltrials.gov) - Oct 28, 2020 P1/2, N=1, Terminated, Phase classification: P3 --> P2/3 | N=266 --> 401 | Trial completion date: Oct 2023 --> Feb 2025 | Trial primary completion date: Aug 2023 --> Jan 2024 N=60 --> 1 | Trial completion date: Jun 2023 --> Oct 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Oct 2020; Adverse events of the first patient
- |||||||||| itacitinib (INCB039110) / Incyte
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation (clinicaltrials.gov) - Oct 28, 2020 P2, N=0, Withdrawn, N=60 --> 1 | Trial completion date: Jun 2023 --> Oct 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Oct 2020; Adverse events of the first patient N=60 --> 0 | Trial completion date: Aug 2021 --> Sep 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2021 --> Sep 2020
- |||||||||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte
Trial completion date, Trial primary completion date: A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101) (clinicaltrials.gov) - Sep 2, 2020 P1/2, N=88, Active, not recruiting, Initiation date: Jun 2020 --> Nov 2020 Trial completion date: Aug 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020
- |||||||||| Journal: Potential Drugs Targeting Early Innate Immune Evasion of SARS-Coronavirus 2 via 2'-O-Methylation of Viral RNA. (Pubmed Central) - May 23, 2020
After molecular dynamics calculations of the stability of the binding modes of high-scoring nsp16/nsp10-drug complexes, we considered their pharmacological overlapping with functional modules of the virus-host interactome that is relevant to the viral lifecycle, and to the clinical features of COVID-19. Some of the predicted drugs (e.g., tegobuvir, sonidegib, siramesine, antrafenine, bemcentinib, itacitinib, or phthalocyanine) might be suitable for repurposing to pharmacologically reactivate innate immune restriction and antagonism of SARS-CoV-2 RNAs lacking 2'-O-methylation.
- |||||||||| Jakafi (ruxolitinib) / Novartis, Incyte, itacitinib (INCB039110) / Incyte
Enrollment closed, Enrollment change, Combination therapy: A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis (clinicaltrials.gov) - May 18, 2020 P2, N=23, Active, not recruiting, Suspended --> Recruiting Recruiting --> Active, not recruiting | N=42 --> 23
- |||||||||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte
Trial completion date, Trial primary completion date: A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101) (clinicaltrials.gov) - May 7, 2020 P1/2, N=88, Active, not recruiting, Trial completion date: Mar 2020 --> Dec 2020 Trial completion date: May 2020 --> Aug 2020 | Trial primary completion date: Apr 2020 --> Jul 2020
- |||||||||| itacitinib (INCB039110) / Incyte, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka, gemcitabine / Generic mfg.
P1/2 data, Journal: A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. (Pubmed Central) - Mar 26, 2020 P1b/2 Itacitinib plus chemotherapy demonstrated acceptable safety and clinical activity in patients with advanced solid tumors including pancreatic cancers. This study was terminated early (sponsor's decision) based on negative phase III results for a JAK1/2 inhibitor in previously treated advanced pancreatic cancer.
- |||||||||| itacitinib (INCB039110) / Incyte
Enrollment open, Combination therapy: Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) - Mar 24, 2020 P1/2, N=28, Recruiting, This study was terminated early (sponsor's decision) based on negative phase III results for a JAK1/2 inhibitor in previously treated advanced pancreatic cancer. Active, not recruiting --> Recruiting
- |||||||||| itacitinib (INCB039110) / Incyte
Enrollment closed, Combination therapy: Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) - Mar 23, 2020 P1/2, N=28, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| itacitinib (INCB039110) / Incyte
Trial completion date: An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis (clinicaltrials.gov) - Feb 25, 2020 P2, N=125, Active, not recruiting, Preclinical data reveal insights into vulnerabilities created in myeloma cells by BET protein inhibition and potential strategies that can be leveraged in clinical studies to enhance the activity of INCB054329. Trial completion date: Jan 2020 --> Jun 2020
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