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NCT01999985 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01999985: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01999985 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999985, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to: * Find out if the study drugs Afatinib and Dasatinib can be safely given together to patients with lung cancer * Learn how these two drugs work in cancer cells when they are combined * Learn more about the side effects of these two drugs when combined * Find the highest doses of the study drugs Afatinib and Dasatinib that can be given safely without causing serious side effects
Primary Outcome
The MTD for this combined treatment will be defined as either: 1. The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or, 2. Afatinib at the highest tolerated dose investigated (40 mg by mouth \[PO\] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily).
Interventions
- DRUG Dasatinib - 1A
- DRUG Afatinib - 1A
- DRUG Dasatinib - 1B
- DRUG Afatinib - 1B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-12-31 |
| Est. Completion | 2019-05-30 |
| Phase | Phase 1 |
What the finished NCT01999985 record still lists
NCT01999985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Dasatinib - 1A is the first listed.
NCT01999985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01999985 about?
NCT01999985 is a clinical study titled "Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)". The purpose of this study is to: * Find out if the study drugs Afatinib and Dasatinib can be safely given together to patients with lung cancer * Learn how these two drugs work in cancer cells when they are combined * Learn more about the side effects of these two drugs when combined * Find the hig...
What is the current status of trial NCT01999985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-12-31. Estimated completion is 2019-05-30.
What interventions are being tested in trial NCT01999985?
The interventions under investigation include: Dasatinib - 1A (DRUG), Afatinib - 1A (DRUG), Dasatinib - 1B (DRUG), Afatinib - 1B (DRUG).
Who is sponsoring clinical trial NCT01999985?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01999985's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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