Trial · NCT02567799
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity | Day 1 up to 6 weeks or maximum tolerated dose | Participants | COUNT_OF_PARTICIPANTS | |
| 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. | Participants | NUMBER | |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng*hr/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng*hr/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng*hr/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng/mL | MEAN |
| 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 | Only participants that had blood draws for pharmacokinetics were analyzed | ng*hr/mL | MEAN |
| 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 | Analysis population only includes subjects that had a baseline measurement during the screening visit | Percent change from baseline | MEAN |
| 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) | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | Number of participants vary based on the number of subjects that completed a CT scan each timepoint | Mean Change from Baseline (cm) | MEAN |
| SECONDARY | DLCO as Measured by Pulmonary Function Test (PFT) | Screening and months 6 & 13 post radiation therapy completion | Number of participants varies based on the number of study subjects that received each assessment | mL/mmHg/Min | MEAN |
| 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 | Participants | COUNT_OF_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 | Number of participants at each time point vary based on the number of study participants that completed the assessment | FACT-L Total Score | MEAN |
| 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 | Number of participants at each time point vary based on the number of study participants that completed the assessment | UCSD-SOBQ Total Score | MEAN |
| 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 | Number of participants at each time point vary based on the number of study participants that completed the assessment | Swallowing Diary Score | MEAN |
| SECONDARY | Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 | Number of participants analyzed at each time point varies based on the number of subjects available for pharmacokinetic blood draw | ng/mL | MEAN |
| SECONDARY | Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 | Number of participants at each time point varies based on the number of participants with blood sample available for analysis. | ng/mL | MEAN |
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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