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NCT02616393 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases
A Phase 2 study of Non-Small Cell Lung Cancer and Brain Metastases, sponsored by Kadmon Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 7
- Study locations
NCT02616393: Completed Phase 2 study of Non-Small Cell Lung Cancer and Brain Metastases, sponsored by Kadmon Corporation.
NCT02616393 is a Phase 2 study of Non-Small Cell Lung Cancer and Brain Metastases that has completed, run by Kadmon Corporation. The registered enrollment target is 36 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02616393, a Phase 2 study of Non-Small Cell Lung Cancer and Brain Metastases, has completed, sponsored by Kadmon Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 7
- Study locations
Study Summary
A study to assess the activity of tesevatinib in subjects with non-small cell lung cancer (NSCLC) and activating epidermal growth factor receptor (EGFR) mutations who have disease progression with Brain Metastases (BM) or Leptomeningeal Metastases (LM) or who have either BM or LM at initial presentation (IP)
Primary Outcome
The best overall response rates (ORRs) of subjects who had brain tumors and exhibited either a complete response (CR) or a partial responder (PR) to therapy divided by the total number of subjects treated with tesevatinib 300 mg PO QD. Response rates are in accordance with RECIST Version 1.1 criteria. Since such brain metastases (BM) tumors can either affect the central nervous system (CNS) or not affect the CNS (non-CNS), they were categorized into CNS and non-CNS subsets. Because leptomeningea
Conditions Studied
Interventions
- DRUG Tesevatinib
Study Locations (7)
California
- Beverly Hills Cancer Center - Beverly Hills
- USC Norris Oncology/Hematology Newport Beach - Newport Beach
- John Wayne Cancer Institute - Santa Monica
Colorado
- University of Colorado Cancer Center - Aurora
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- UT M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-11 |
| Est. Completion | 2018-04-03 |
| Phase | Phase 2 |
What the finished NCT02616393 record still lists
NCT02616393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Tesevatinib is the first listed.
NCT02616393 lists 7 locations in 5 states (California, Colorado, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT02616393 about?
NCT02616393 is a clinical study titled "Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal Metastases". A study to assess the activity of tesevatinib in subjects with non-small cell lung cancer (NSCLC) and activating epidermal growth factor receptor (EGFR) mutations who have disease progression with Brain Metastases (BM) or Leptomeningeal Metastases (LM) or who have either BM or LM at initial presenta...
What is the current status of trial NCT02616393?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2015-11. Estimated completion is 2018-04-03.
What conditions does trial NCT02616393 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Brain Metastases, Leptomeningeal Metastases.
What interventions are being tested in trial NCT02616393?
The interventions under investigation include: Tesevatinib (DRUG).
Who is sponsoring clinical trial NCT02616393?
This trial is sponsored by Kadmon Corporation, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02616393 being conducted?
This trial has 7 study locations across California, Colorado, District of Columbia, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02616393's enrollment target sits among peer trials
36 378th of 454 higher than 75 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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