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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01953926
Registration number
NCT01953926
Ethics application status
Date submitted
26/09/2013
Date registered
1/10/2013
Date last updated
12/03/2024
Titles & IDs
Public title
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
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Scientific title
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
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Secondary ID [1]
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2013-002872-42
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Secondary ID [2]
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PUMA-NER-5201
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Universal Trial Number (UTN)
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Trial acronym
SUMMIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Neratinib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Paclitaxel
Experimental: Neratinib monotherapy - Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, and lung cancers containing EGFR exon 18 mutations.
Cohorts closed to enrollment in prior amendments: HER2 mutant cancers including bladder/urinary, colorectal, endometrial, breast HR-positive, TNBC HR-negative, lung, gastroesophageal, biliary, and ovarian; HER3 mutant solid tumor NOS; HER4 mutant solid tumor NOS; fibrolamellar carcinoma and EGFR brain.
Experimental: Neratinib and Trastuzumab - Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers.
Cohorts closed to enrollment in in prior amendments: colorectal, lung cancer HER2 mutant.
Experimental: Neratinib, Fulvestrant and Trastuzumab (Randomized) - Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.
Experimental: Neratinib, Fulvestrant and Trastuzumab (Non-Randomized) - Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with or without CDK4/6i) breast cancers.
Experimental: Neratinib and Paclitaxel - Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.
Experimental: Neratinib and Fulvestrant - Neratinib and Fulvestrant in HER2 mutated (HR-positive) breast cancers.
Treatment: Drugs: Neratinib
240 mg administered orally, once daily with food, continuously in 28 day cycles
Treatment: Drugs: Fulvestrant
500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle
Treatment: Drugs: Trastuzumab
Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter
Treatment: Drugs: Paclitaxel
80mg/m^2 administered IV on Days 1, 8, and 15 of every 4 week cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
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Assessment method [1]
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Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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Timepoint [1]
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From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
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Primary outcome [2]
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Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
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Assessment method [2]
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Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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Timepoint [2]
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From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
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Primary outcome [3]
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Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
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Assessment method [3]
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Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST.
RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels
Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.
Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Part
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Timepoint [3]
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From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks
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Secondary outcome [1]
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Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)
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Assessment method [1]
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Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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Timepoint [1]
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From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
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Secondary outcome [2]
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Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
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Assessment method [2]
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Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0.
For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments.
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Timepoint [2]
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From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months.
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Secondary outcome [3]
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Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
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Assessment method [3]
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Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
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Timepoint [3]
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From first response to first disease progression or death, assessed up to 58 months
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Secondary outcome [4]
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Duration of Response (DOR) by Investigator Review (All Cohorts)
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Assessment method [4]
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Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
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Timepoint [4]
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From first response to first disease progression or death, assessed up to 58 months
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Secondary outcome [5]
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Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
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Assessment method [5]
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Percentage of participants with CR + PR + stable disease =16, or =24 weeks for breast cancer, from the date of enrollment.
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Timepoint [5]
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From enrollment date to first documented response or stable disease =16, or =24 weeks for breast cancer, assessed up to 58 months
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Secondary outcome [6]
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Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
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Assessment method [6]
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Percentage of participants with CR + PR + stable disease =16, or =24 weeks for breast cancer, from the date of enrollment.
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Timepoint [6]
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From enrollment date to first documented response or stable disease =16, or =24 weeks for breast cancer, assessed up to 58 months
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Secondary outcome [7]
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Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
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Assessment method [7]
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Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
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Timepoint [7]
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From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
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Secondary outcome [8]
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Progression-Free Survival (PFS) by Investigator Review (All Cohorts)
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Assessment method [8]
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Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
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Timepoint [8]
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From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
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Secondary outcome [9]
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Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [9]
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The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose
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Timepoint [9]
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From first dose through 28 days after the last dose, assessed up to 75 months.
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Eligibility
Key inclusion criteria
- Provide written informed consent
- Histologically confirmed cancers for which no curative therapy exists
- Documented HER2 or EGFR exon 18 mutation
- Participants must agree and commit to use appropriate methods of contraception as
outlined in the protocol
- At least one measurable lesion, defined by RECIST v1.1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants harboring ineligible somatic HER2 mutations
- Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib,
afatinib, dacomitinib, neratinib) is excluded with the following exception: patients
with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other
pan HER or EGFR TKIs remain eligible
- Participants who are receiving any other anticancer agents
- Symptomatic or unstable brain metastases
- Women who are pregnant or breast-feeding
There are additional inclusion and exclusion criteria. The study center will determine if
criteria for participation are met.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/01/2023
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Sample size
Target
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Accrual to date
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Final
582
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment postcode(s) [1]
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8006 - East Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Florida
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Georgia
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Illinois
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Louisiana
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Massachusetts
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Missouri
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Wisconsin
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Belgium
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Leuven
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Canada
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British Columbia
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Denmark
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Kopenhagen
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France
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France
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Paris
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France
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Bordeaux
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France
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Lyon
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Ireland
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Leinster
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Cremona
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Italy
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Milano
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Italy
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Roma
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Italy
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Torino
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Korea, Republic of
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Seoul
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Serbia
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Belgrade
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Puma Biotechnology, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the
efficacy and safety of neratinib as monotherapy or in combination with other therapies in
participants with HER (EGFR, HER2) mutation-positive solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01953926
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Trial related presentations / publications
Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE Jr, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018 Feb 8;554(7691):189-194. doi: 10.1038/nature25475. Epub 2018 Jan 31. Erratum In: Nature. 2019 Feb;566(7745):E11-E12.
Smyth LM, Piha-Paul SA, Won HH, Schram AM, Saura C, Loi S, Lu J, Shapiro GI, Juric D, Mayer IA, Arteaga CL, de la Fuente MI, Brufksy AM, Spanggaard I, Mau-Sorensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg LS, Gonzalez-Farre X, Cervantes A, Bidard FC, Gorelick AN, Lanman RB, Nagy RJ, Ulaner GA, Chandarlapaty S, Jhaveri K, Gavrila EI, Zimel C, Selcuklu SD, Melcer M, Samoila A, Cai Y, Scaltriti M, Mann G, Xu F, Eli LD, Dujka M, Lalani AS, Bryce R, Baselga J, Taylor BS, Solit DB, Meric-Bernstam F, Hyman DM. Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer. Cancer Discov. 2020 Feb;10(2):198-213. doi: 10.1158/2159-8290.CD-19-0966. Epub 2019 Dec 5.
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Public notes
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Contacts
Principal investigator
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Chief Scientific Officer
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Address
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Puma Biotechnology, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01953926
Download to PDF