Condition or disease | Intervention/treatment | Phase |
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Solid Tumor, Adult | Drug: Neratinib Drug: Divalproex Sodium | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 81 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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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.
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Drug: Neratinib
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).
Other Names:
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 10, 2019 | ||||||||
First Posted Date ICMJE | April 18, 2019 | ||||||||
Last Update Posted Date | March 11, 2021 | ||||||||
Actual Study Start Date ICMJE | May 1, 2019 | ||||||||
Estimated Primary Completion Date | January 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca | ||||||||
Official Title ICMJE | Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers | ||||||||
Brief Summary | To determine the recommended phase 2 dose (RP2D) of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors. | ||||||||
Detailed Description | This study is a single-arm, open-label, phase 1/2 trial to determine the recommended phase 2 dose of neratinib and sodium valproate when given in combination to patients with advanced solid tumors in 28 day cycles. The phase II portion of the study will evaluate the combination at the RP2D in 3 cohorts of RAS mutated tumors, KRAS mutant colorectal cancer, KRAS mutant pancreatic cancer, and K or N RAS mutant solid tumors. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumor, Adult | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||||||
* 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 |
81 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 31, 2024 | ||||||||
Estimated Primary Completion Date | January 31, 2022 (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 | NCT03919292 | ||||||||
Other Study ID Numbers ICMJE | MCC-17-13821 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Virginia Commonwealth University | ||||||||
Study Sponsor ICMJE | Virginia Commonwealth University | ||||||||
Collaborators ICMJE | Puma Biotechnology, Inc. | ||||||||
Investigators ICMJE |
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PRS Account | Virginia Commonwealth University | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |