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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN261201200078C | Other Grant/Funding Number | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Henry Ford Health System | OTHER |
| Medical College of Wisconsin | OTHER |
| University of Maryland, Baltimore |
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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.
This is an open-label, single-arm, ascending dose Phase I/II study of BIO 300 Oral Suspension given in combination with paclitaxel/carboplatin and radiotherapy in subjects with stage II, III, or IV NSCLC who are candidates for combined chemoradiotherapy.
A minimum of 6 subjects will be accrued sequentially at each dose level of BIO 300. BIO 300 will be administered daily for the entire course of concurrent chemoradiotherapy, a minimum of 6 weeks; in combination with standard paclitaxel / carboplatin chemotherapy and radiotherapy.
The initial dose of BIO 300 will be administered on Day 1, Visit 2 in which safety data (adverse events, electrocardiograms (ECGs), results of safety laboratory determinations), pharmacokinetic (PK) and pharmacodynamic (PD) data will be collected. PK data will be collected from a minimum of six (6) study subjects from each cohort. PD data will be collected from all subjects in each study cohort. Day 1 of chemotherapy will be scheduled at the discretion of the investigator provided the subject has completed a minimum of 1 day of BIO 300 dosing. BIO 300 will be administered in combination with the chemotherapy components of the protocol (paclitaxel and carboplatin). During the first or second chemotherapy infusion, additional safety, PK and PD data will be collected. Day 1 of radiation therapy (RT) may be scheduled at the discretion of the investigator provided the subject has completed a minimum of 2 days of BIO 300 dosing. BIO 300 will continue to be administered daily; paclitaxel and carboplatin will be administered weekly and radiotherapy will be administered daily until a total dose of 60-70 Gy has been administered. During the period of combined BIO 300 and chemoradiotherapy (6-7 weeks), additional safety, PK and PD data will be collected weekly. An interim data analysis will be completed once the highest dose cohort concludes chemoradiation therapy, in an effort to determine the optimal biological dose. Following analysis, there will be an option to enroll up to an additional 12 subjects at the optimal biological dose. At the conclusion of the study, primary and secondary outcome measures will be evaluated. Data will be analyzed from all cohorts to determine the oncologic response, safety of BIO 300, and a recommended BIO 300 dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | Ascending dose evaluation of BIO 300 Oral Suspension (3 dose levels) given in combination with paclitaxel/carboplatin and radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIO 300 Oral Suspension | Drug | Cohort 1: BIO 300 500 mg Cohort 2: BIO 300 1,000 mg Cohort 3: BIO 300 1,500 mg Cohort 4: BIO 300 Optimal dose (TBD) BIO 300 dose will be given daily, 7 days/week (Week 1, day 1 through week 6) The 2nd and 3rd dosing cohort (1,000 and 1,500 mg/day) will begin following the accrual of a minimum of 6 subjects at the previous dose level, dose escalation to the next BIO 300 dose level will be allowed to occur when a cohort has completed concurrent chemoradiotherapy with fewer than 33% Dose Limiting Toxicities (DLTs) attributed to BIO 300 Oral Suspension. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity | 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. | Day 1 up to 6 weeks or maximum tolerated dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| Mean Maximum Serum Concentration (Cmax) of BIO 300 Administered in the Absence of Chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Weight loss greater than 10% in prior 4 weeks
Prior malignancy in which they received any thoracic radiotherapy unless the treating physician considers it unlikely to impact the clinical outcome of the patient
Patients with concurrent invasive malignancy other than non-melanoma skin cancer or cervical intraepithelial neoplasia unless the treating physician considers it unlikely to impact the clinical outcome of the patient
An active infection or with a fever ≥ 38.5°C
Poorly controlled intercurrent illnesses
Patients with a prior thoracotomy within 1 week of study registration
Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
Patients with any of the following are not eligible:
Patients must not have had a clinically significant cardiac event within 6 months before entry; or the presence of any other uncontrolled cardiovascular conditions that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
Patients with a history of arrhythmia or asymptomatic sustained ventricular tachycardia are not eligible. Patients with atrial fibrillation with well-controlled ventricular rate on medication, are eligible.
Psychiatric conditions, social situations or substance abuse that precludes the ability of the subject to cooperate with the requirements of the trial and protocol therapy
Grade 2 or higher peripheral neuropathy
Known history of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS), hepatitis B or C.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Women who are breastfeeding are not eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Michael D. Kaytor, PhD | Humanetics Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States | ||
| Henry Ford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37652301 | Background | Simone CB 2nd, Serebrenik AA, Gore EM, Mohindra P, Brown SL, Wang D, Chetty IJ, Vujaskovic Z, Menon S, Thompson J, Fine G, Kaytor MD, Movsas B. Multicenter Phase 1b/2a Clinical Trial of Radioprotectant BIO 300 Oral Suspension for Patients With Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):404-414. doi: 10.1016/j.ijrobp.2023.08.048. Epub 2023 Aug 29. | |
| 28489488 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BIO 300 Oral Suspension (500 mg/Day) | BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
| FG001 | BIO 300 Oral Suspension (1000 mg/Day) | BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
| FG002 | BIO 300 Oral Suspension (1500 mg/Day) | BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concurrent Chemoradiotherapy |
|
| |||||||||||||||||||||
| Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BIO 300 Oral Suspension (500 mg/Day) | BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
| BG001 | BIO 300 Oral Suspension (1000 mg/Day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity | 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. | Posted | Count of Participants | Participants | Day 1 up to 6 weeks or maximum tolerated dose |
|
Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants.
The CTCAE Version 4.03 was used to grade all AEs. All reported terms and descriptions for AEs were coded using CTCAE Version 4.03.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIO 300 Oral Suspension (500 mg/Day) | BIO 300 Oral Suspension (500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael D. Kaytor | Humanetics Corporation | 952-400-0406 | mkaytor@humaneticscorp.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2018 | Sep 25, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019833 | Genistein |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
Not provided
Not provided
| OTHER |
| Milwaukee VA Medical Center | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Paclitaxel | Drug | During the Concurrent Therapy period, paclitaxel 45 mg/m2 will be administered by intravenous drip weekly during weeks 1-6. During the Consolidation Therapy period, paclitaxel 200 mg/m2 will be administered by intravenous drip two times, 21 days apart. |
|
|
| Carboplatin | Drug | During the Concurrent Therapy period, area under the curve (AUC) = 2mg* min/mL will be administered by intravenous drip weekly during weeks 1-6. During the Consolidation Therapy period, carboplatin AUC = 6mg*min/mL will be administered by intravenous drip two times, 21 days apart. |
|
|
| Radiotherapy | Radiation | Radiation treatment will be scheduled at the discretion of the investigator provided the subject has completed a minimum of 2 days of BIO 300 dosing. Subjects will receive radiation therapy 5 days per week, once daily fractions, 1.8-2.0 Gy per fraction, for 6-7 weeks. |
|
| Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Percent Change From Baseline in Expression Levels of Serum TGF-beta Isoform 1 (TGFB1) | Measuring change from baseline (screening visit) of 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 |
| Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria | 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. | Screening, visits 20, 37, 38, 39, 40, 41 & 42 (through visit 41 for surgical participants) |
| Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan | Tumor diameter was measured in centimeters. Mean change in tumor diameter from the baseline measurement at screening is reported. | Screening, visits 20 and 3, 6, 11 & 13 months post radiation therapy |
| DLCO as Measured by Pulmonary Function Test (PFT) | Screening and months 6 & 13 post radiation therapy completion |
| 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 |
| Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy-Lung Scale Trial Outcome Index (FACT-L TOI) Patient Reported Outcome Questionnaire. | 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. | Screening and months 3, 6, & 13 post radiation therapy completion |
| Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. | 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. | Screening and months 3, 6, & 13 post radiation therapy completion |
| Extent of Esophagitis by Patient Reported Swallowing Diary | 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. | Screening, weeks 1, 2, 3, 4, 5, & 6 and months 3 & 6 post radiation therapy completion |
| Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 |
| Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin | 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). | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 |
| FVC as Measured by Pulmonary Function Test (PFT) | Screening and months 6 & 13 post radiation therapy completion |
| FEV1 as Measured by Pulmonary Function Test (PFT) | Screening and months 6 & 13 post radiation therapy completion |
| Detroit |
| Michigan |
| 48202-2689 |
| United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Zablocki VA Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Derived |
| Citrin DE, Prasanna PGS, Walker AJ, Freeman ML, Eke I, Barcellos-Hoff MH, Arankalayil MJ, Cohen EP, Wilkins RC, Ahmed MM, Anscher MS, Movsas B, Buchsbaum JC, Mendonca MS, Wynn TA, Coleman CN. Radiation-Induced Fibrosis: Mechanisms and Opportunities to Mitigate. Report of an NCI Workshop, September 19, 2016. Radiat Res. 2017 Jul;188(1):1-20. doi: 10.1667/RR14784.1. Epub 2017 May 10. |
| Progressive Disease |
|
| NOT COMPLETED |
|
|
BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7).
| BG002 | BIO 300 Oral Suspension (1500 mg/Day) | BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Initial Tumor Stage | Tumors were staged using the American Joint Committee on Cancer (AJCC) TNM system. The lower the lung cancer stage, the less the cancer has spread and the better the prognosis. | Count of Participants | Participants |
|
| Tumor Histology | Count of Participants | Participants |
|
| Primary Tumor Location | Count of Participants | Participants |
|
| OG002 | BIO 300 Oral Suspension (1500 mg/Day) | BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). |
|
|
| Secondary | Number of Participants With Adverse Events Throughout the Study | Posted | Number | Participants | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng*hr/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng*hr/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng*hr/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng/mL | 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 | Only participants that had blood draws for pharmacokinetics were analyzed | Posted | Mean | Standard Deviation | ng*hr/mL | 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) | Measuring change from baseline (screening visit) of TGF-beta isoform 1 (TGFB1) | Analysis population only includes subjects that had a baseline measurement during the screening visit | Posted | Mean | Standard Deviation | Percent change from baseline | 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 |
|
|
|
| Secondary | Rate of Progressive Disease Evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) Criteria | 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. | Posted | Count of Participants | Participants | Screening, visits 20, 37, 38, 39, 40, 41 & 42 (through visit 41 for surgical participants) |
|
|
|
| Secondary | Change in Tumor Diameter as Measured by Diagnostic Computerized Tomography (CT) Scan | Tumor diameter was measured in centimeters. Mean change in tumor diameter from the baseline measurement at screening is reported. | Number of participants vary based on the number of subjects that completed a CT scan each timepoint | Posted | Mean | Standard Deviation | Mean Change from Baseline (cm) | Screening, visits 20 and 3, 6, 11 & 13 months post radiation therapy |
|
|
|
| Secondary | DLCO as Measured by Pulmonary Function Test (PFT) | Number of participants varies based on the number of study subjects that received each assessment | Posted | Mean | Standard Deviation | mL/mmHg/Min | Screening and months 6 & 13 post radiation therapy completion |
|
|
|
| Secondary | Number of Participants With Pulmonary Fibrosis Assessed by Four-dimensional Computerized Tomography (4D-CT) | Posted | Count of Participants | Participants | 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. | 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. | Number of participants at each time point vary based on the number of study participants that completed the assessment | Posted | Mean | Standard Deviation | FACT-L Total Score | Screening and months 3, 6, & 13 post radiation therapy completion |
|
|
|
| Secondary | Quality of Life (QOL) as Measured by University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) Patient Reported Outcome Questionnaire. | 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. | Number of participants at each time point vary based on the number of study participants that completed the assessment | Posted | Mean | Standard Deviation | UCSD-SOBQ Total Score | Screening and months 3, 6, & 13 post radiation therapy completion |
|
|
|
| Secondary | Extent of Esophagitis by Patient Reported Swallowing Diary | 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. | Number of participants at each time point vary based on the number of study participants that completed the assessment | Posted | Mean | Standard Deviation | Swallowing Diary Score | Screening, weeks 1, 2, 3, 4, 5, & 6 and months 3 & 6 post radiation therapy completion |
|
|
|
| Secondary | Mean Weekly BIO 300 Trough Levels, Serum Concentration of BIO 300 | Number of participants analyzed at each time point varies based on the number of subjects available for pharmacokinetic blood draw | Posted | Mean | Standard Deviation | ng/mL | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 |
|
|
|
| Secondary | Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin | 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). | Number of participants at each time point varies based on the number of participants with blood sample available for analysis. | Posted | Mean | Standard Deviation | ng/mL | Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6 |
|
|
|
| Secondary | FVC as Measured by Pulmonary Function Test (PFT) | Number of participants varies based on the number of study subjects that received each assessment | Posted | Mean | Standard Deviation | Liters | Screening and months 6 & 13 post radiation therapy completion |
|
|
|
| Secondary | FEV1 as Measured by Pulmonary Function Test (PFT) | Number of participants varies based on the number of study subjects that received each assessment | Posted | Mean | Standard Deviation | Liters | Screening and months 6 & 13 post radiation therapy completion |
|
|
|
| 2 |
| 7 |
| 3 |
| 7 |
| 7 |
| 7 |
| EG001 | BIO 300 Oral Suspension (1000 mg/Day) | BIO 300 Oral Suspension (1000 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). | 0 | 7 | 1 | 7 | 7 | 7 |
| EG002 | BIO 300 Oral Suspension (1500 mg/Day) | BIO 300 Oral Suspension (1500 mg/day) was given daily, 7 days/week (Week 1, day 1 through the end of concurrent chemoradiotherapy, Weeks 6-7). | 1 | 7 | 2 | 7 | 7 | 7 |
| Cardiac Arrest | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection/Pneumonia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema Limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infusion Related Reaction | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain (Non-Cardiac) | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Radiation Dermatitis | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Serum Amylase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight Loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypomagnesemi | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tremors | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D013812 | Therapeutics |
| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| After consolidation therapy |
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| 3 months post-RT |
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| 6 months post-RT |
|
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| Stable Disease |
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| Progressive Disease |
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| 3 Months Post-RT |
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| 6 Months Post-RT |
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| 9 Months Post-RT |
|
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| 11 Months Post-RT |
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| 13 Months Post-RT |
|
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| 6 months post-RT |
|
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| 13 months post-RT |
|
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| 3 months post-RT |
|
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| 6 months post-RT |
|
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| 13 months post-RT |
|
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| 3 months post-RT |
|
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| 6 months post-RT |
|
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| 13 months post-RT |
|
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| 3 months post-RT |
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| 6 months post-RT |
|
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| 6 months post-RT |
|
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| 13 months post-RT |
|
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| 6 months post-RT |
|
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| 13 months post-RT |
|
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