NCT01953926Phase 2Terminated

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Study sponsor: Puma Biotechnology, Inc. · PBYI

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-01-02Actual

Enrollment · participants582Actual

Source updated2024-03-12Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Treatments or interventions studied

NeratinibDrugAlso known as Nerlynx
FulvestrantDrugAlso known as Faslodex
TrastuzumabDrugAlso known as Herceptin
PaclitaxelDrugAlso known as Taxol

Primary outcomes · main study measures

Read the study measures

measure: Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort); description: 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; timeFrame: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months; measure: Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort); description: 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; timeFrame: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months; measure: Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts); description: 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; timeFrame: From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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