Tandutinib

Overview

MLN518 is a novel, oral, small molecule designed to inhibit type III receptor tyrosine kinases, including FLT3, (platelet-derived growth-factor receptor) PDGFR and c-KIT. Tyrosine kinases are enzymes involved in several cellular processes and are known to be activated in cancer cells to drive tumor growth. AML patients with FLT3 mutations experience earlier disease relapse and shorter survival rates compared to patients without these mutations. Approximately 25 to 30 percent of all adult AML patients have a mutation of the FLT3 gene. The use of MLN518 to treat AML has been granted fast-track status by the U.S. Food and Drug Administration. Phase I/II trials are underway.

Indication

Investigated for use/treatment in leukemia (myeloid).

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer	2006/12/07	NCT00408902	Phase 2	Completed	National Cancer Institute (NCI)
Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases	2006/10/19	NCT00390468	Phase 2	Completed	National Cancer Institute (NCI)
Tandutinib in Treating Patients With Recurrent or Progressive Glioblastoma	2006/09/21	NCT00379080	Phase 1	Completed	National Cancer Institute (NCI)
A Phase 2 Study of Tandutinib in Patients With Newly Diagnosed Acute Myelogenous Leukemia Who Are Considered Ineligible For or Who Decline Treatment With Standard Induction Therapy	2006/03/01	NCT00297921	Phase 1	Withdrawn	Millennium Pharmaceuticals, Inc.
MLN518 in Combination With Standard Induction Chemo. for Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia	2006/01/10	NCT00274248	Phase 1	Completed	Millennium Pharmaceuticals, Inc.
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)	2003/07/10	NCT00064584	Phase 1	Completed	Millennium Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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