Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01953926 · ClinicalTrials.gov registry record · Phase 2
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
A Phase 2 study, sponsored by Puma Biotechnology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 582
- Enrollment target
NCT01953926: Clinical Trial Phase 2 study, sponsored by Puma Biotechnology.
NCT01953926 is a Phase 2 study that was terminated before completion, run by Puma Biotechnology. The registered enrollment target is 582 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (338% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01953926, a Phase 2 study, was terminated before completion, sponsored by Puma Biotechnology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 582 participants
- Enrollment target
Study 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.
Primary Outcome
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 longes
Interventions
- DRUG Trastuzumab
- DRUG Neratinib
- DRUG Paclitaxel
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 582 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2023-01-02 |
| Phase | Phase 2 |
Why NCT01953926 stopped before completion
NCT01953926 is an interventional study that assigns participants to a tested intervention. The registered 582 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (338% higher).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT01953926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01953926 about?
NCT01953926 is a clinical study titled "Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations". 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.
What is the current status of trial NCT01953926?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 582 participants. The study started on 2013-09-30. Estimated completion is 2023-01-02.
What interventions are being tested in trial NCT01953926?
The interventions under investigation include: Trastuzumab (DRUG), Neratinib (DRUG), Paclitaxel (DRUG), Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT01953926?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01953926's enrollment target sits among peer trials
582 58th of 2000 higher than 1,943 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06350097 · 582 participants · Phase 3
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
- NCT06563895 · 582 participants · Phase 3
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
- NCT06819007 · 582 participants · Phase 3
Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
- NCT03840083 · 584 participants · NA
Sleep-dependent Learning in Aging
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI