Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT04781374 |
Recruitment Status :
Withdrawn
(Withdrawal of funding)
First Posted : March 4, 2021
Last Update Posted : July 11, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | February 26, 2021 | ||||||||||||||
First Posted Date ICMJE | March 4, 2021 | ||||||||||||||
Last Update Posted Date | July 11, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | May 21, 2021 | ||||||||||||||
Actual Primary Completion Date | September 24, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Response Rate to Neratinib [ Time Frame: 84 days ] defined by PSA response and/or radiographic response after three 28-day cycles of treatment.
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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 | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer | ||||||||||||||
Official Title ICMJE | A Phase 2 Study of Neratinib in Patients With Metastatic Castration Resistant Prostate Cancer and Increased Human Epithelial Growth Factor Receptor 2 (HER2) Signaling | ||||||||||||||
Brief Summary | This research study is examining whether Neratinib has any activity in participants with prostate cancer that has spread and is no longer responding to hormonal treatment. - The names of the study drug involved in this study is neratinib. |
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Detailed Description | In this research study, investigators are testing neratinib in prostate cancer that has spread and is no longer responding to hormonal therapies. This research study involves testing tumors for evidence of increased HER2 signaling, and treating those who do have increased HER2 signaling with a targeted therapy. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. - The names of the study drug involved in this study is neratinib. It is expected that about 14 people will take part in this research study. 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 drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved neratinib for this specific disease but it has been approved for other uses. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Neratinib
Oral, once daily with 28 consecutive days defined as a treatment cycle, dosage per protocol ,
Other Name: Nerlynx
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Study Arms ICMJE | Experimental: Neratinib
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. - Neratinib-once daily with 28 consecutive days defined as a treatment cycle Intervention: Drug: Neratinib
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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 | Withdrawn | ||||||||||||||
Actual Enrollment ICMJE |
0 | ||||||||||||||
Original Estimated Enrollment ICMJE |
14 | ||||||||||||||
Actual Study Completion Date ICMJE | September 24, 2021 | ||||||||||||||
Actual Primary Completion Date | September 24, 2021 (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 | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04781374 | ||||||||||||||
Other Study ID Numbers ICMJE | 20-659 | ||||||||||||||
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 | David J. Einstein, Beth Israel Deaconess Medical Center | ||||||||||||||
Original Responsible Party | David J. Einstein, MD, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Beth Israel Deaconess Medical Center | ||||||||||||||
Original Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Beth Israel Deaconess Medical Center | ||||||||||||||
Verification Date | July 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |