Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01646125 · ClinicalTrials.gov registry record · Phase 2
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01646125: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01646125 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01646125, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.
Primary Outcome
Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria
Interventions
- DRUG Docetaxel
- DRUG Pemetrexed
- DRUG AUY922
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-11-23 |
| Est. Completion | 2015-11-04 |
| Phase | Phase 2 |
Why NCT01646125 stopped before completion
NCT01646125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT01646125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01646125 about?
NCT01646125 is a clinical study titled "An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations". The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedu...
What is the current status of trial NCT01646125?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-11-23. Estimated completion is 2015-11-04.
What interventions are being tested in trial NCT01646125?
The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), AUY922 (DRUG).
Who is sponsoring clinical trial NCT01646125?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01646125's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
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