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NCT02525653 · ClinicalTrials.gov registry record · Phase 2
Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
A Phase 2 study of Lung Cancer and Untreated Stage IV or Recurrent Squamous Cell Lung Cancers, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 6
- Study locations
NCT02525653: Completed Phase 2 study of Lung Cancer and Untreated Stage IV or Recurrent Squamous Cell Lung Cancers, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02525653 is a Phase 2 study of Lung Cancer and Untreated Stage IV or Recurrent Squamous Cell Lung Cancers that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 40 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02525653, a Phase 2 study of Lung Cancer and Untreated Stage IV or Recurrent Squamous Cell Lung Cancers, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators would like to determine the percentage of patients with squamous cell lung cancers who experience shrinkage of their tumors following treatment with this regimen. This combination of drugs is not a standard therapy for patients with squamous cell lung cancers. However, each of these drugs, when given alone or with other chemotherapies, is FDA-approved for the treatment of this disease.
Primary Outcome
defined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Conditions Studied
Interventions
- DRUG gemcitabine
- DRUG albumin-bound paclitaxel
Study Locations (6)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Rockville Centre - Rockville Centre
- Memorial Sloan Kettering Westchester - Sleepy Hollow
Florida
- Miami Cancer Institute Baptist Health South Florida - Miami
New Jersey
- Memorial Sloan Kettering at Basking Ridge - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-05 |
| Phase | Phase 2 |
What the finished NCT02525653 record still lists
NCT02525653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which gemcitabine is the first listed.
NCT02525653 lists 6 locations in 3 states (New York, Florida, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02525653 about?
NCT02525653 is a clinical study titled "Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers". The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators would like to determine the percentage of patients with squamous cell lung cancers who experience shrinkage of their ...
What is the current status of trial NCT02525653?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2015-08. Estimated completion is 2019-05.
What conditions does trial NCT02525653 study?
This clinical trial studies the following conditions: Lung Cancer, Untreated Stage IV or Recurrent Squamous Cell Lung Cancers.
What interventions are being tested in trial NCT02525653?
The interventions under investigation include: gemcitabine (DRUG), albumin-bound paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02525653?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02525653 being conducted?
This trial has 6 study locations across Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02525653's enrollment target sits among peer trials
40 294th of 409 higher than 108 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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