Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00620594 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 183
- Enrollment target
NCT00620594: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00620594 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 183 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (205% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00620594, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 183 participants
- Enrollment target
Study Summary
This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part: Dose escalation part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab): Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients. Once the MTD has been defined, the safety expansion parts of the trial will be opened for enrollment. Safety dose expansion part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab): Patients will be treated with BEZ235, as single agent or in combination with trastuzumab, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects.
Interventions
- DRUG BEZ235
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2006-12-21 |
| Est. Completion | 2013-01-08 |
| Phase | Phase 1 |
What the finished NCT00620594 record still lists
NCT00620594 is an interventional study that assigns participants to a tested intervention. The registered 183 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 (205% higher).
The record links to 0 conditions, and to 1 intervention - of which BEZ235 is the first listed.
NCT00620594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00620594 about?
NCT00620594 is a clinical study titled "A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer". This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part: Dose escalation part (advanced solid tumors, including patients with breast cancer ...
What is the current status of trial NCT00620594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 183 participants. The study started on 2006-12-21. Estimated completion is 2013-01-08.
What interventions are being tested in trial NCT00620594?
The interventions under investigation include: BEZ235 (DRUG).
Who is sponsoring clinical trial NCT00620594?
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 NCT00620594's enrollment target sits among peer trials
183 297th of 2000 higher than 1,702 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
- NCT03859297 · 183 participants · NA
Mechanisms of Rumination Change in Adolescent Depression
- NCT04270591 · 183 participants · Phase 1
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
- NCT06764615 · 183 participants · Phase 2
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
- NCT06872684 · 183 participants · NA
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
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