INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
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ClinicalTrials.gov Identifier: NCT02977780 |
Recruitment Status :
Recruiting
First Posted : November 30, 2016
Last Update Posted : August 9, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | November 18, 2016 | ||||||||
First Posted Date ICMJE | November 30, 2016 | ||||||||
Last Update Posted Date | August 9, 2023 | ||||||||
Actual Study Start Date ICMJE | February 9, 2017 | ||||||||
Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Overall Survival in Experimental Arms Compared with Standard Therapy [ Time Frame: 2 years ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) | ||||||||
Official Title ICMJE | INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) | ||||||||
Brief Summary | This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are :
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the study drug works in treating a specific disease. "Investigational" means that the drug is being studied. In this research study, the investigators are looking to compare the effects, good and bad, of the standard of care with the three investigational agent sub-studies Abemaciclib, Neratinib, CC115 to help people with Glioblastoma including the specific molecular changes in the genes and proteins. The FDA has approved Temozolomide (temodar) as a treatment for this disease, however the FDA has not approved Abemaciclib, CC115, Neratinib, QBS10072S for any diseases. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Glioblastoma | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Groot J, Ott M, Wei J, Kassab C, Fang D, Najem H, O'Brien B, Weathers SP, Matsouka CK, Majd NK, Harrison RA, Fuller GN, Huse JT, Long JP, Sawaya R, Rao G, MacDonald TJ, Priebe W, DeCuypere M, Heimberger AB. A first-in-human Phase I trial of the oral p-STAT3 inhibitor WP1066 in patients with recurrent malignant glioma. CNS Oncol. 2022 Jun 1;11(2):CNS87. doi: 10.2217/cns-2022-0005. Epub 2022 May 16. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
250 | ||||||||
Original Estimated Enrollment ICMJE |
280 | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2025 | ||||||||
Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02977780 | ||||||||
Other Study ID Numbers ICMJE | 16-443 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Patrick Wen, MD, Dana-Farber Cancer Institute | ||||||||
Original Responsible Party | Brian Alexander, MD, Dana-Farber Cancer Institute, Director, CNS Radiation Oncology | ||||||||
Current Study Sponsor ICMJE | Patrick Wen, MD | ||||||||
Original Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||
Verification Date | August 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |