Multi-center, Open-label, Dose-escalating Phase I/II Trial of GS-9219 Administered Once Every Three Weeks Intravenously to Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma or Multiple Myeloma

Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts.
Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.

Start Date01 Jul 2007

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Rabacfosadine

100 Translational Medicine associated with Rabacfosadine

100 Patents (Medical) associated with Rabacfosadine

Literatures (Medical) associated with Rabacfosadine

01 Jul 2024·Journal of Veterinary Internal Medicine

Early progression during or after cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy indicates poor outcome with rescue protocols in dogs with multicentric lymphoma

Article

Author: Burton, Jenna H ; Curran, Kaitlin M ; Thamm, Douglas H ; Wolf-Ringwall, Amber ; Parker, Ashley S

AbstractBackgroundDogs with lymphoma that fail cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (CHOP) before completion of their protocol are commonly thought to have poor long‐term outcome, but no previous studies have evaluated the effect of early relapse on progression‐free interval (PFI) or overall survival time (OST) for patients undergoing rescue chemotherapy.ObjectiveCorrelate rescue treatment outcomes in dogs with multicentric lymphoma with outcomes after 1st‐line CHOP chemotherapy.MethodsData were collected from 6 previous retrospective or prospective studies in 187 dogs with multicentric lymphoma that received 1st‐line CHOP chemotherapy and then received either lomustine (CCNU), L‐asparaginase and prednisone (LAP), or rabacfosadine (RAB, Tanovea), with or without prednisone or L‐asparaginase.ResultsThe PFI after initiation of CHOP chemotherapy was significantly associated with response rate postprogression, PFI, and postrescue survival time (ST) for both rescue protocols. Immunophenotype (B‐ vs T‐cell) was not significantly associated with response, PFI or OST for LAP but was significantly associated with response and PFI for RAB.ConclusionDogs that experience short PFI during or after 1st‐line CHOP chemotherapy had lower response rates to rescue treatment, with shorter PFI and ST. Immunophenotype did not significantly affect outcome with LAP but was associated with PFI for RAB.

01 Jun 2024·Veterinary and Comparative Oncology

Alternating rabacfosadine and doxorubicin for treatment of naïve canine lymphoma

Article

Author: Saba, Corey F ; Thamm, Douglas H ; Phillips, Brenda S ; Wright, Zachary M ; Fan, Timothy M

AbstractThe current standard of care treatment for canine lymphoma is a multi‐agent, CHOP‐based chemotherapy protocol. Single agent doxorubicin (DOX) is less burdensome; however, multi‐agent chemotherapy protocols are often superior. The recently approved drug rabacfosadine (RAB, Tanovea) provides an attractive option for combination therapy with DOX, as both drugs demonstrate efficacy against lymphoma and possess different mechanisms of action. A previous study evaluating alternating RAB/DOX reported an overall response rate (ORR) of 84%, with a median progression‐free survival time (PFS) of 194 days. The aim of this prospective trial was to evaluate the same protocol in an additional population of dogs. Fifty‐nine dogs with treatment naïve lymphoma were enrolled. RAB (1.0 mg/kg IV) was alternated with DOX (30 mg/m2 IV) every 21 days for up to six total treatments (3 cycles). Response assessment and adverse event (AE) evaluation were performed every 21 days using VCOG criteria. The ORR was 93% (79% CR, 14% PR). The median time to maximal response was 21.5 days; median PFS was 199 days. T cell immunophenotype and lack of treatment response were predictive of inferior outcomes. AEs were mostly gastrointestinal. Six dogs developed presumed or confirmed pulmonary fibrosis; four were grade 5. One dog experienced grade 3 extravasation injury with RAB that resolved with supportive treatment. These data mirror those of the previously reported RAB/DOX study, and support the finding that alternating RAB/DOX is a reasonable treatment option for canine lymphoma.

01 Aug 2022·Current Microbiology

The Impact of D614G Mutation of SARS-COV-2 on the Efficacy of Anti-viral Drugs: A Comparative Molecular Docking and Molecular Dynamics Study

Article

Author: Tüzün, Burak ; Mehrabani, Mehrnaz ; Azadpour, Mahdiyeh ; Faramarz, Sanaz ; Poustforoosh, Alireza ; Pardakhty, Abbas ; Hashemipour, Hassan ; Nematollahi, Mohammad Hadi

D614G is one of the most reported mutations in the spike protein of SARS-COV-2 that has altered some crucial characteristics of coronaviruses, such as rate of infection and binding affinities. The binding affinity of different antiviral drugs was evaluated using rigid molecular docking. The reliability of the docking results was evaluated with the induced-fit docking method, and a better understanding of the drug-protein interactions was performed using molecular dynamics simulation. The results show that the D614G variant could change the binding affinity of antiviral drugs and spike protein remarkably. Although Cytarabine showed an appropriate interaction with the wild spike protein, Ribavirin and PMEG diphosphate exhibited a significant binding affinity to the mutated spike protein. The parameters of the ADME/T analysis showed that these drugs are suitable for further in-vitro and in-vivo investigation. D614G alteration affected the binding affinity of the RBD and its receptor on the cell surface.

100 Deals associated with Rabacfosadine

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KEGG	Wiki	ATC	Drug Bank
D10723	Rabacfosadine	-	DB12762

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 2	Czechia	Gilead Sciences, Inc.	01 Jul 2007
Chronic Lymphocytic Leukemia	Phase 2	United States	Gilead Sciences, Inc.	01 Jul 2007
Chronic Lymphocytic Leukemia	Phase 2	Russia	Gilead Sciences, Inc.	01 Jul 2007
Multiple Myeloma	Phase 2	United States	Gilead Sciences, Inc.	01 Jul 2007
Non-Hodgkin Lymphoma	Phase 2	Russia	Gilead Sciences, Inc.	01 Jul 2007
Non-Hodgkin Lymphoma	Phase 2	Czechia	Gilead Sciences, Inc.	01 Jul 2007
Non-Hodgkin Lymphoma	Phase 2	United States	Gilead Sciences, Inc.	01 Jul 2007
Recurrent Chronic Lymphoid Leukemia	Phase 2	Russia	Gilead Sciences, Inc.	01 Jul 2007
Recurrent Chronic Lymphoid Leukemia	Phase 2	Czechia	Gilead Sciences, Inc.	01 Jul 2007
Recurrent Chronic Lymphoid Leukemia	Phase 2	United States	Gilead Sciences, Inc.	01 Jul 2007

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