Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02051751 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer
A Phase 1 study of Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 5
- Study locations
NCT02051751: Completed Phase 1 study of Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, sponsored by Novartis Pharmaceuticals.
NCT02051751 is a Phase 1 study of Neoplasms, Breast Neoplasms, Head and Neck Neoplasms that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02051751, a Phase 1 study of Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 5
- Study locations
Study Summary
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination
Primary Outcome
A dose-limiting toxicity (DLT) is an adverse event or abnormal laboratory value assessed as being unrelated to disease, disease progression, inter-current illness, or concomitant medications, and that occurs within the first cycle of treatment with BYL719 plus paclitaxel and meets any of the pre-defined criteria.
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG BYL719
Study Locations (5)
Arkansas
- Highlands Oncology Group - Fayetteville
Indiana
- Horizon Oncology Center BioAdvance - Lafayette
Other
- Novartis Investigative Site - Toulouse
MI
- Novartis Investigative Site - Milan
Catalonia
- Novartis Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-03-05 |
| Est. Completion | 2016-08-19 |
| Phase | Phase 1 |
What the finished NCT02051751 record still lists
NCT02051751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Neoplasms, Breast Neoplasms, Head and Neck Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Paclitaxel is the first listed.
NCT02051751 lists 5 locations in 5 states (Arkansas, Indiana, Other).
Frequently Asked Questions
What is clinical trial NCT02051751 about?
NCT02051751 is a clinical study titled "A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer". Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination
What is the current status of trial NCT02051751?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2014-03-05. Estimated completion is 2016-08-19.
What conditions does trial NCT02051751 study?
This clinical trial studies the following conditions: Neoplasms, Breast Neoplasms, Head and Neck Neoplasms.
What interventions are being tested in trial NCT02051751?
The interventions under investigation include: Paclitaxel (DRUG), BYL719 (DRUG).
Who is sponsoring clinical trial NCT02051751?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02051751 being conducted?
This trial has 5 study locations across Arkansas, Indiana, MI, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02051751's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
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