Clinical Trial DRUG M12-356
- A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 in Combination with Radiation Plus Temozolomide or Temozolomide Alone for Subjects with Glioblastoma Multiforme
- Principal Investigator
- Priya Kumthekar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG M12-356
- The purpose of this study is to study the safety of the study drug (ABT-414), to find highest safe dose of the study drug, and to study how a patient's body handles this new drug in combination with radiation and temozolomide or in combination with temozolomide alone.
- The usual treatment for glioblastoma multiforme (GBM) is radiation therapy (RT) in combination with temozolomide (TMZ). TMZ is a chemotherapy drug that is approved by the Food and Drug Administration (FDA) for the treatment of GBM. In addition, RT is commonly used in combination with TMZ for the treatment of newly diagnosed glioblastoma. The combination of the study drug and TMZ plus RT or the study drug and TMZ is considered investigational. The study drug when given together with TMZ plus RT or TMZ alone may make the TMZ and RT or TMZ work better and kill cancer cells more efficiently. The study drug may also stop cancer cells from growing on their own.
Some of the eligibility criteria include:
- Participants must have advanced (grade IV) glioblastoma.
- Participants must be 18 or older.
- Description of Treatment
- This study is made up of two dose escalation “Arms” as well as an “Expanded Cohort.” The dose escalation “Arms” are to access safety and highest safe dose of the study drug that can be given without causing health problems. In the first arm (Arm A), the study drug will be administered in combination with standard of care RT and TMZ in research participant’s with newly diagnosed GBM. In the second arm (Arm B), the study drug will be administered in combination with TMZ in research participant’s with GBM that have either just completed RT and TMZ therapy or in research participant’s with recurrent GBM. The “Expanded Cohort” will assess the safety of the study drug at the recommended Phase 2 dose defined in Arm A and Arm B in combination with standard of care RT and TMZ.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 04-Dec-16 08:14 AM
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