Delving into the Latest Updates on Ifosfamide/Mesna with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ifex/Mesnex Kit

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

Hemorrhagic cystitisTesticular Neoplasms

Inactive Indication-

Originator Organization

Baxter Healthcare Corp.

Active Organization

Baxter Healthcare Corp.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (14 Aug 1987),

Hemorrhagic cystitisTesticular Neoplasms

Regulation-

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Structure/Sequence

Molecular FormulaC2H6NaO3S2

InChIKeyPYTISYCTLQTCTM-UHFFFAOYSA-N

CAS Registry19767-45-4

View All Structures (2)

Prostate cancer is the 2nd most common cancer in men worldwide. Based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and PARP inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. However, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. In this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.

Start Date01 Nov 2016

Sponsor / Collaborator

Yonsei University

NCT00823719

/ CompletedPhase 2

A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation

The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.

Start Date01 May 2009

Sponsor / Collaborator

GSK Plc

NCT00137995

/ CompletedPhase 3IIT

Randomized Study of ICE Plus RITUXIMAB Versus DHAP Plus Rituximab in Previously Treated Patients With Diffuse Large B-cell Lymphoma, Followed by Randomized Maintenance With Rituximab

The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20.
The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP.
The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival.
The goal is to obtain a 15% increase of event free survival at 2 years.

Start Date01 Jun 2003

Sponsor / Collaborator

The Lymphoma Study Association

100 Clinical Results associated with Ifosfamide/Mesna

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100 Translational Medicine associated with Ifosfamide/Mesna

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100 Patents (Medical) associated with Ifosfamide/Mesna

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2

Literatures (Medical) associated with Ifosfamide/Mesna

01 Sep 1999·Annals of OncologyQ1 · MEDICINE

Saturable metabolism of continuous high-dose ifosfamide with Mesna and GM-CSF: A pharmacokinetic study in advanced sarcoma patients

Q1 · MEDICINE

Article

Author: P. Honegger ; S. Leyvraz ; T. von Briel ; A. Küpfer ; A.V. Boddy ; S.-F. Hsu Schmitz ; R. Schaad ; J. Brunner ; C. Sessa ; T. Cerny

BACKGROUNDThe aim of this study was to assess the pharmacology, toxicity and activity of high-dose ifosfamide mesna +/- GM-CSF administered by a five-day continuous infusion at a total ifosfamide dose of 12-18 g/m2 in adult patients with advanced sarcomas.PATIENTS AND METHODSBetween January 1991 and October 1992 32 patients with advanced or metastatic sarcoma were entered the study. Twenty-seven patients were pretreated including twenty-three with prior ifosfamide at less than 8 g/m2 total dose/cycle. In 25 patients (27 cycles) extensive pharmacokinetic analyses were performed.RESULTSThe area under the plasma concentration-time curve (AUC) for ifosfamide increased linearly with dose while the AUC's of the metabolites measured in plasma by thin-layer chromatography did not increase with dose, particularly that of the active metabolite isophosphoramide mustard. Furthermore the AUC of the inactive carboxymetabolite did not increase with dose. Interpatient variability of pharmacokinetic parameters was high. Dose-limiting toxicity was myelosuppression at 18 g/m2 total dose with grade 4 neutropenia in five of six patients and grade 4 thrombocytopenia in four of six patients. Therefore the maximum tolerated dose was considered to be 18 g/m2 total dose. There was one CR and eleven PR in twenty-nine evaluable patients (overall response rate 41%).CONCLUSIONBoth the activation and inactivation pathways of ifosfamide are non-linear and saturable at high-doses although the pharmacokinetics of the parent drug itself are dose linear. Ifosfamide doses greater than 14-16 g/m2 per cycle appear to result in a relative decrease of the active metabolite isophosphoramide mustard. These data suggest a dose-dependent saturation or even inhibition of ifosfamide metabolism by increasing high dose ifosfamide and suggest the need for further metabolic studies.

01 Jan 1986·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapieQ2 · MEDICINE

CNS-side effects induced by Ifosfamide-Mesna in children with osteosarcomas.

Q2 · MEDICINE

Article

Author: Cornille, H ; Desbois, J G ; Delépine, G ; Jasmin, C ; Taillard, F ; Delépine, N

The authors have had the opportunity to see two cases of CNS side effects of Ifosfamide-Mesna association in children. Data in the medical literature about this subject remains poor. Only a few observations are available. In the referred cases, CNS side effects (lethargy, apathy and mutism) appeared a few hours after the second day of treatment and were spontaneously reversible in a few days. After reviewing possible mechanisms of this toxicity the authors pointed out the necessity to keep this type of side effects of Ifosfamide-Mesna association in mind, and to avoid it in susceptible patients.

100 Deals associated with Ifosfamide/Mesna

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhagic cystitis	United States	Baxter Healthcare Corp.	14 Aug 1987
Testicular Neoplasms	United States	Baxter Healthcare Corp.	14 Aug 1987

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GOG (ASCO2009)	Not Applicable	Uterine Carcinosarcoma Adjuvant	51	CIM (Carboplatin, Ifosfamide, Mesna)	xxucwtjvgd(dmbvaapiys) = qeihgzdofr kzevpwkhrx (qudljixmmo ) View more	-	20 May 2009
GOG (ASCO2009)	Not Applicable	Uterine Carcinosarcoma Adjuvant	51	Other chemotherapy regimens	xxucwtjvgd(dmbvaapiys) = onqsrvnvgh kzevpwkhrx (qudljixmmo ) View more	-	20 May 2009
ASCO2006	Not Applicable	Recurrent Uterine Sarcoma	-	Ifosfamide, Mesna, Doxorubicin	qcfjbhysmu(pxkerhkwzt) = sbqqjzdmet ajadkjdypd (ddncggyloh, 32% - 67%)	-	20 Jun 2006