Carcinoma, Non-Small-Cell LungPhase 1/2NSCLCNCT02567799
BIO 300 Non-Small Cell Lung Cancer Study
A Phase 1/2 study testing BIO 300 Oral Suspension, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Humanetics Corporation at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- BIO 300 Oral Suspension, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2015to Sep 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of NSCLC
- Stage II, III, or IV NSCLC for whom radiation therapy of 60 Gy and concurrent weekly paclitaxel/carboplatin is recommended
- Up to three small (≤ 3 cm each) lung oligometastases will be allowed and/or one oligometastasis at any other site in the body
- Eastern Cooperative Oncology Group Performance Scale (ECOG PS) of 0 or 1
- Forced expiratory volume at one second (FEV1): best value obtained pre- or post-bronchodilator must be ≥ 1.0 liters/second or > 50% predicted value
- Adequate bone marrow reserve
Show all 11Show fewer
- Adequate hepatic reserve
- Adequate renal function
- Female subjects of childbearing potential must have a negative pregnancy test
- Female subjects of childbearing potential and male subjects with female sexual partners of childbearing potential must agree to use an effective method of contraception
- Ability to read and provide written informed consent
Who cannot join
- 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
Show all 20Show fewer
- 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:
- Previous history of Corrected QT Interval (QTc ) prolongation resulting from medication that required discontinuation of that medication
- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age;
- Presence of left bundle branch block (LBBB);
- QTc with Fridericia's correction that is unmeasurable, or ≥ 480 msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be < 480 msec in order for the patient to be eligible for the study;
- Subjects taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes are not eligible if QTc ≥ 460 msec.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Henry Ford Hospital
Detroit, Michigan, 48202-2689
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295
About this study
Official title: A Phase I/II Clinical Study Evaluating the Safety and Effectiveness of BIO 300 Oral Suspension in Patients Receiving Chemoradiation Therapy for Non-Small Cell Lung Cancer (NSCLC)
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.
Read the detailed description
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BIO 300 Oral Suspension, Paclitaxel, Carboplatin, Radiotherapy
- Keywords
- Lung Neoplasms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO 300 Oral SuspensionDrug
Also called genistein, 5, 7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one
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.
PaclitaxelDrug
Also called Onxol, Taxol
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.
CarboplatinDrug
Also called Paraplatin, CARBOplatin Novaplus
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.
RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Ascending dose evaluation of BIO 300 Oral Suspension (3 dose levels) given in combination with paclitaxel/carboplatin and radiotherapy. Receives: Drug: BIO 300 Oral Suspension; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 up to 6 weeks or maximum tolerated dose
Secondary outcomes (21)
Number of Participants With Adverse Events Throughout the Study
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Screening, visits 20 and 3, 6, 11 & 13 months post radiation therapy
DLCO as Measured by Pulmonary Function Test (PFT)
Measured: Screening and months 6 & 13 post radiation therapy completion
Number of Participants With Pulmonary Fibrosis Assessed by Four-dimensional Computerized Tomography (4D-CT)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6
FVC as Measured by Pulmonary Function Test (PFT)
Measured: Screening and months 6 & 13 post radiation therapy completion
FEV1 as Measured by Pulmonary Function Test (PFT)
Measured: Screening and months 6 & 13 post radiation therapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Henry Ford Health System, Medical College of Wisconsin, University of Maryland, Baltimore, Milwaukee VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael D. Kaytor, PhD, Study director, Humanetics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567799
- Sponsor's protocol ID
- CL0101-01
- Other IDs
- HHSN261201200078C
- Acronym
- NSCLC
- Status last verified
- Jan 2024
- First submitted
- 9 Jul 2015
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37652301Citrin 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.
PubMed 28489488
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating the Safety and Effectiveness of BIO 300 Oral Suspension in Patients Receiving Chemoradiation Therapy for Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02567799
- Acronym / sponsor ID
- NSCLC / CL0101-01
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Lung Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Humanetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Henry Ford Health System, Medical College of Wisconsin, University of Maryland, Baltimore, Milwaukee VA Medical Center
- Study start
- Nov 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Drug: BIO 300 Oral Suspension, Drug: Paclitaxel, Drug: Carboplatin, Radiation: RadiotherapyAscending dose evaluation of BIO 300 Oral Suspension (3 dose levels) given in combination with paclitaxel/carboplatin and radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological or cytological confirmation of NSCLC
- Stage II, III, or IV NSCLC for whom radiation therapy of 60 Gy and concurrent weekly paclitaxel/carboplatin is recommended
- Up to three small (≤ 3 cm each) lung oligometastases will be allowed and/or one oligometastasis at any other site in the body
- Eastern Cooperative Oncology Group Performance Scale (ECOG PS) of 0 or 1
- Forced expiratory volume at one second (FEV1): best value obtained pre- or post-bronchodilator must be ≥ 1.0 liters/second or > 50% predicted value
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIO 300 Oral SuspensionAlso: genistein, 5, 7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-oneCohort 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. | Drug | Single-arm |
| PaclitaxelAlso: Onxol, TaxolDuring 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. | Drug | Single-arm |
| CarboplatinAlso: Paraplatin, CARBOplatin NovaplusDuring 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. | Drug | Single-arm |
| RadiotherapyRadiation 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. | Radiation | Single-arm |
Primary outcome
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity
Time frame: 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.
21 secondary outcomes
Number of Participants With Adverse Events Throughout the Study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Screening, visits 20 and 3, 6, 11 & 13 months post radiation therapy
DLCO as Measured by Pulmonary Function Test (PFT)
Time frame: Screening and months 6 & 13 post radiation therapy completion
Number of Participants With Pulmonary Fibrosis Assessed by Four-dimensional Computerized Tomography (4D-CT)
Time frame: 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.
Time frame: 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.
Time frame: Screening and months 3, 6, & 13 post radiation therapy completion
Extent of Esophagitis by Patient Reported Swallowing Diary
Time frame: 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
Time frame: Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6
Weekly Paclitaxel Trough Levels, Plasma Concentration of Paclitaxel and Carboplatin
Time frame: Concurrent chemoradiotherapy weeks 1, 2, 3, 4, 5 and 6
FVC as Measured by Pulmonary Function Test (PFT)
Time frame: Screening and months 6 & 13 post radiation therapy completion
FEV1 as Measured by Pulmonary Function Test (PFT)
Time frame: Screening and months 6 & 13 post radiation therapy completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37652301Simone 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.
- Derived from this study: PubMed 28489488Citrin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D. Kaytor, PhD study director
Humanetics Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BIO 300 Oral Suspension, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Humanetics Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity (time frame: Day 1 up to 6 weeks or maximum tolerated dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567799, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.