Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01822613 · ClinicalTrials.gov registry record · Phase 1
Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01822613: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01822613 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01822613, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.
Primary Outcome
The open-label dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or Recommended Phase II Dose (s) guided by the safety (incidence of dose limiting toxicities), efficacy, pharmacokinetics and pharmacodynamics data.
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Irinotecan
- DRUG BYL719
- DRUG LJM716
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-07-26 |
| Est. Completion | 2016-06-03 |
| Phase | Phase 1 |
What the finished NCT01822613 record still lists
NCT01822613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01822613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01822613 about?
NCT01822613 is a clinical study titled "Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)". To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.
What is the current status of trial NCT01822613?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-07-26. Estimated completion is 2016-06-03.
What interventions are being tested in trial NCT01822613?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Irinotecan (DRUG), BYL719 (DRUG), LJM716 (DRUG).
Who is sponsoring clinical trial NCT01822613?
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 NCT01822613's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
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