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Generic Name: temozolomide

Summary for Generic Name: temozolomide

Drug Master File Entries: see list14
Suppliers: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: temozolomide

Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Status: Completed Condition: Glioblastoma; Glioma; Astrocytoma

Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway
Status: Recruiting Condition: Histologically Confirmed Medulloblastoma; Activation of the Sonic Hedgehog (SHH) Pathway

Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Status: Active, not recruiting Condition: Glioblastoma; Gliomas

Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
Status: Completed Condition: Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma
Status: Active, not recruiting Condition: Malignant Glioma; Glioblastoma Multiforme; Gliosarcoma

Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas
Status: Completed Condition: Glioblastoma; Gliosarcoma; Brain Tumor

Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma
Status: Completed Condition: Glioblastoma Multiforme; Anaplastic Glioma

Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
Status: Active, not recruiting Condition: Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Childhood Spinal Cord Neoplasm; Untreated Childhood Brain Stem Glioma; Untreated Childhood Cerebral Astrocytoma

A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Status: Recruiting Condition: Glioblastoma

Neo-adjuvant Treatment With Temozolomide and Bevacizumab Previous to Temozolomide Plus Radiation Plus Bevacizumab Therapy in Unresectable Glioblastoma
Status: Active, not recruiting Condition: Glioblastomas

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Merck Sharp Dohme
CAPSULE;ORAL021029Aug 11, 1999RXNo5,260,291*PED<disabled>Y
Merck Sharp Dohme
CAPSULE;ORAL021029Oct 19, 2006RXNo5,260,291*PED<disabled>Y
Merck Sharp Dohme
CAPSULE;ORAL021029Aug 11, 1999RXYes5,260,291*PED<disabled>Y
CAPSULE;ORAL078879Mar 1, 2010RXNo<disabled>
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