Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01962103 · ClinicalTrials.gov registry record · Phase 1
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT01962103: Completed Phase 1 study, sponsored by Celgene.
NCT01962103 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01962103, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen, patients will be enrolled according to the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these tumors.
Primary Outcome
A DLT was defined as investigational product (IP)-related adverse events occurring during the DLT assessment period that led to treatment discontinuation or met one of the following criteria: - Common Terminology Criteria for Adverse Events (CTCAE) Grade (Gr) 3 or 4 nonhematologic toxicity (excluding transient transaminitis) - CTCAE Gr 3 or 4 nausea or vomiting that persisted \> 5 days despite maximal anti-emetic treatment - CTCAE Gr 4 thrombocytopenia or anemia that persisted \> 7 days or requi
Interventions
- DRUG nab-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2013-12-04 |
| Est. Completion | 2018-11-06 |
| Phase | Phase 1 |
What the finished NCT01962103 record still lists
NCT01962103 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 1 intervention - of which nab-paclitaxel is the first listed.
NCT01962103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01962103 about?
NCT01962103 is a clinical study titled "Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors". The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen, patients will be enroll...
What is the current status of trial NCT01962103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2013-12-04. Estimated completion is 2018-11-06.
What interventions are being tested in trial NCT01962103?
The interventions under investigation include: nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01962103?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01962103's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 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
- NCT05491668 · 107 participants
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI
- NCT06041594 · 107 participants · NA
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
- NCT06081426 · 107 participants · NA
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
- NCT06527599 · 107 participants · NA
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
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