Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03919292|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Drug: Neratinib Drug: Divalproex Sodium||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: Neratinib + Divalproex Sodium
Neratinib by mouth (PO) once daily + Divalproex Sodium (Valproate) by mouth (PO) twice daily on days 1-28 of each course.
Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion). Doses of Neratinib are escalated in small groups of patients during the dose expansion portion of the study.
Other Name: Nerlynx
Drug: Divalproex Sodium
Combination of Neratinib and Divalproex Sodium (Valproate) will be given to patients with advanced solid tumors (dose escalation) and Ras-mutated cancers (dose expansion).
- Determination of Recommended Phase 2 Dose (RP2D) [ Time Frame: 28 Days ]RP2D for the combination of neratinib and sodium valproate that is less than or the same as the maximum tolerated dose (MTD).
- Evaluation of Treatment Related Adverse Events of Neratinib combined with Sodium Valproate [ Time Frame: 13 Months ]To determine the safety and toxicity of the combination of neratinib and sodium valproate by characterizing, grading, and evaluating the serious adverse events, and adverse events the patients experience utilizing the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
- Antitumor Effects [ Time Frame: 13 Months ]Tumor response, based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), in patients evaluable for response.
- Progression Free Survival (PFS) [ Time Frame: 13 Months ]To evaluate PFS as the duration from the start of Cycle 1 Day 1 to the date of tumor progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919292
|Contact: Massey SIIT Team||804-628-9238||Masseysiit@vcu.edu|
|Contact: Andrew Poklepovic, MD||877-462-7739|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Massey SIIT Team 804-628-9238 Masseysiit@vcu.edu|
|Contact: Andrew Poklepovic, MD 877-462-7739|
|Principal Investigator: Andrew Poklepovic, MD|
|Principal Investigator:||Andrew Poklepovic, MD||Massey Cancer Center|