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NCT02650752 · ClinicalTrials.gov registry record · Phase 1
Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02650752: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02650752 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02650752, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to see if capecitabine can be taken safely with different doses of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases) and/or in spinal fluid (leptomeningeal disease).
Primary Outcome
During the standard 3+3, the probability that dose escalation will occur at any stage during MTD determination is a function of the underlying DLT rate at the current dose level. This probability can be calculated as the sum of the binomial probabilities of the following two outcomes that would permit escalation to occur: 1. No DLT observed in the first three patients. 2. One DLT is observed in the first three patients followed by no DLT observed in three additional patients at the same dose le
Interventions
- DRUG Lapatinib in Tandem With Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-01-06 |
| Est. Completion | 2021-01-22 |
| Phase | Phase 1 |
What the finished NCT02650752 record still lists
NCT02650752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Lapatinib in Tandem With Capecitabine is the first listed.
NCT02650752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02650752 about?
NCT02650752 is a clinical study titled "Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases". The purpose of this study is to see if capecitabine can be taken safely with different doses of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases) and/or in spinal fluid (leptomeningeal disease).
What is the current status of trial NCT02650752?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-01-06. Estimated completion is 2021-01-22.
What interventions are being tested in trial NCT02650752?
The interventions under investigation include: Lapatinib in Tandem With Capecitabine (DRUG).
Who is sponsoring clinical trial NCT02650752?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02650752's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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
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