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NCT02567799 · ClinicalTrials.gov registry record · Phase 1
BIO 300 Non-Small Cell Lung Cancer Study
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Humanetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 4
- Study locations
NCT02567799: Completed Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Humanetics Corporation.
NCT02567799 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that has completed, run by Humanetics Corporation. The registered enrollment target is 21 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02567799, a Phase 1 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Humanetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy and chemotherapy in patients with non-small cell lung cancer. Based on preclinical data the investigators hypothesize that BIO 300 Oral Suspension will reduce the incidence of radiation-induced pneumonitis and pulmonary fibrosis.
Primary Outcome
Adverse events of CTCAE v4.0 grade 3 or higher that were possibly, probably or definitely related to BIO 300 Oral Suspension and have occurred before or during concurrent chemoradiotherapy were considered dose limiting toxicities.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiotherapy
- DRUG BIO 300 Oral Suspension
Study Locations (4)
Wisconsin
- Medical College of Wisconsin - Milwaukee
- Zablocki VA Medical Center - Milwaukee
Maryland
- University of Maryland School of Medicine - Baltimore
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-11 |
| Est. Completion | 2020-09 |
| Phase | Phase 1 |
What the finished NCT02567799 record still lists
NCT02567799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT02567799 reports a single indexed study location in Wisconsin, Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT02567799 about?
NCT02567799 is a clinical study titled "BIO 300 Non-Small Cell Lung Cancer Study". The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy and chemotherapy in patients with non-small cell lung cancer. Based on preclinical data the investigators hypothesize that BIO 300 Oral Susp...
What is the current status of trial NCT02567799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2015-11. Estimated completion is 2020-09.
What conditions does trial NCT02567799 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT02567799?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiotherapy (RADIATION), BIO 300 Oral Suspension (DRUG).
Who is sponsoring clinical trial NCT02567799?
This trial is sponsored by Humanetics Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02567799 being conducted?
This trial has 4 study locations across Maryland, Michigan, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02567799's enrollment target sits among peer trials
21 117th of 130 higher than 14 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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