Trial · NCT02567799
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity | Day 1 up to 6 weeks or maximum tolerated dose | 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. |
| Secondary | Number of Participants With Adverse Events Throughout the Study | Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants. | |
| Secondary | Mean Maximum Serum Concentration (Cmax) of BIO 300 Administered in the Absence of Chemotherapy | Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose | |
| Secondary | Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 Administered in the Absence of Chemotherapy | Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose | |
| Secondary | Mean Maximum Serum Concentration (Cmax) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin | Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose | |
| Secondary | Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin | Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose | |
| Secondary | Mean Maximum Serum Concentration (Cmax) of Paclitaxel When Administered in Combination With BIO 300 | Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose | |
| Secondary | Mean Area Under the Serum Concentration Curve (AUC) of Paclitaxel When Administered in Combination With BIO 300 | Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose | |
| Secondary | Mean Maximum Serum Concentration (Cmax) of Carboplatin When Administered in Combination With BIO 300 | Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose | |
| Secondary | Mean Area Under the Serum Concentration Curve (AUC) of Carboplatin When Administered in Combination With BIO 300 | Week1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose | |
| Secondary | Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) | Screening, once weekly during weeks 1-6 of concurrent chemoradiotherapy prior to BIO 300, paclitaxel, and carboplatin dose, and once at the end of consolidation, 3 months and 6 months after the completion of RT | Measuring change from baseline (screening visit) of TGF-beta isoform 1 (TGFB1) |
| Secondary | Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria | Screening, visits 20, 37, 38, 39, 40, 41 & 42 (through visit 41 for surgical participants) | Best Response Rate reported per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by chest CT imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan | Screening, visits 20 and 3, 6, 11 & 13 months post radiation therapy | Tumor diameter was measured in centimeters. Mean change in tumor diameter from the baseline measurement at screening is reported. |
| Secondary | DLCO as Measured by Pulmonary Function Test (PFT) | Screening and months 6 & 13 post radiation therapy completion | |
| Secondary | Number of Participants With Pulmonary Fibrosis Assessed by Four-dimensional Computerized Tomography (4D-CT) | Screening, visits 20 & 37 and 9 & 13 months post radiation therapy for non-surgical participants; screening only for surgical participants | |
| Secondary | Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) Patient Reported Outcome Questionnaire. | Screening and months 3, 6, & 13 post radiation therapy completion | The Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) questionnaire is a 36-item self-reporting instrument that measures quality of life specific to patients with cancer. Items are rated on a 5 item (point) Likert Scale, from 0 (not at all) to 4 (very much). Total scores range from 0 to 136 and higher scores indicate better quality of life. The FACT-L TOI questionnaire was scored according to FACT-L Scoring Guidelines Version 4. |
| Secondary | Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. | Screening and months 3, 6, & 13 post radiation therapy completion | The UCSD-SOBQ is a 24-item patient self-reported questionnaire where items are scored on a 6-point scale (0, "not at all" to 5, "maximal or unable to-do because of breathlessness"). Total scores range from 0 to 120 and lower scores indicate better quality of life. |
| Secondary | Extent of Esophagitis by Patient Reported Swallowing Diary | Screening, weeks 1, 2, 3, 4, 5, & 6 and months 3 & 6 post radiation therapy completion | The assessment will provide a score (the swallowing questionnaire) from 0 to 5; 1 no problems swallowing; 2 mild soreness only; 3 some difficulty swallowing solids; 4 cannot swallow solids; and 5 cannot swallow liquids. |
| Secondary | Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 | |
| Secondary | Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 | Serum trough levels of paclitaxel and carboplatin were measured. Carboplatin trough levels were below the limit of quantification at all timepoints and are therefore reported as NA (Not Available). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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