Dexanabinol in Patients With Brain Cancer
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | July 16, 2012 | ||||||||
Last Updated Date | July 30, 2012 | ||||||||
Start Date ICMJE | June 2012 | ||||||||
Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Rate of dose limiting toxicities and the maximum tolerated dose (MTD) of weekly dexanabinol [ Time Frame: first 28 days of treatment ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01654497 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Dexanabinol in Patients With Brain Cancer | ||||||||
Official Title ICMJE | A Phase I, Sequential Cohort, Open-Label, Dose-escalation Study of the Safety and CNS Pharmacokinetics of Dexanabinol in Patients With Brain Cancer | ||||||||
Brief Summary | The purpose of this study is to try to determine the maximum safe dose of dexanabinol that can be administered to people with brain cancer. Other purposes of this study are to:
|
||||||||
Detailed Description | Protection from apoptosis is a key survival factor for cancer cells. Dexanabinol is under investigation as a novel anti-cancer therapy based on its tumoricidal activity observed in vitro and in vivo, presumably due to inhibitory activity against NFĸB, TNFα, COX-2 and additional putative targets suck as HAT, FAT and cyclin dependent kinases. Targeted induction of apoptosis in cancer cells versus normal cells provides an attractive strategy for the treatment of brain cancer, a pernicious disease with debilitating neurological side effects and poor prognoses. A single intravenous dosing of dexanabinol has demonstrated safety in humans. Therefore, we are conducting a phase I dose escalation study to examine the safety of multiple dosing of dexanabinol and drug penetration into the brain, and to determine a suitable dose for moving into a phase II trial for efficacy. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
Condition ICMJE | Brain Cancer | ||||||||
Intervention ICMJE | Drug: Dexanabinol
Dexanabinol: intravenous infusion over 3 hours, weekly (i.e., Day 1, 8, 15 and 22 of a 28-day cycle) Four dosing cohorts are initially planned, with the option to enroll additional cohorts based on safety and PK data. Dose Level 1: 2 mg/kg Dose Level 2: 4 mg/kg Dose Level 3: 8 mg/kg Dose Level 4: 16 mg/kg |
||||||||
Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 24 | ||||||||
Estimated Completion Date | December 2014 | ||||||||
Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Hematology:
Biochemistry:
Coagulation:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01654497 | ||||||||
Other Study ID Numbers ICMJE | 111827 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Santosh Kesari, M.D., Ph.D., University of California, San Diego | ||||||||
Study Sponsor ICMJE | Santosh Kesari, M.D., Ph.D. | ||||||||
Collaborators ICMJE | e-Therapeutics PLC | ||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | University of California, San Diego | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |