Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 55 for:    hki-272 OR neratinib

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

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: NCT03786107
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Tracking Information
First Submitted Date December 20, 2018
First Posted Date December 24, 2018
Last Update Posted Date October 3, 2019
Actual Study Start Date March 14, 2019
Estimated Primary Completion Date January 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2018)
Number of Patients Eligible for Neratinib Treatment [ Time Frame: From enrollment date to identification of HER2 positive mutation, assessed up to five years ]
Identification of patients with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03786107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Official Title HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Brief Summary This is a multi-center, observational genomic screening protocol to identify patients whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Patients with histologically confirmed metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 3 to 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible patients and ctDNA will be extracted and sequenced at a central laboratory, using HER2-targeted next generation sequencing (NGS). A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Patients who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Circulating tumor DNA from plasma will be collected from eligible patients. Exons 8 and 17-24 will be sequenced by next generation sequencing (NGS) at a central laboratory.
Sampling Method Non-Probability Sample
Study Population Patients with histologically-confirmed metastatic breast or metastatic cervical cancer
Condition
  • Metastatic Breast Cancer
  • Metastatic Cervical Cancer
Intervention Diagnostic Test: Almac HER-Seq Assay Kit
whole blood sample analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 20, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 15, 2024
Estimated Primary Completion Date January 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Women and men who are ≥18 years old at signing of informed consent
  2. Histologically-confirmed metastatic breast or metastatic cervical cancer
  3. Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  4. Provide written informed consent to participate in the study and for circulating tumor DNA screening
  5. Must be able to provide blood sample(s) for HER2 mutation testing

Exclusion Criteria:

  1. Breast cancer patients with known HER2+ or HER2-amplified tumors
  2. Patients who have received neratinib
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Puma Biotechnology Clinical Operations Senior Director (424) 248-6500 HER-Seq@pumabiotechnology.com
Listed Location Countries Ireland,   Serbia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03786107
Other Study ID Numbers PUMA-NER-9501
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Puma Biotechnology, Inc.
Study Sponsor Puma Biotechnology, Inc.
Collaborators Not Provided
Investigators
Study Director: Clinical Development Chief Medical and Scientific Officer Puma Biotechnology, Inc.
PRS Account Puma Biotechnology, Inc.
Verification Date October 2019