BIO 300 Non-Small Cell Lung Cancer Study

NCT02567799 | Completed Phase 1 Results

• 2 other identifiers: CL0101-01HHSN261201200078C
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (21)

• 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

  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

Study Arms (1)

Single-arm

EXPERIMENTAL

Ascending dose evaluation of BIO 300 Oral Suspension (3 dose levels) given in combination with paclitaxel/carboplatin and radiotherapy.

Drug: BIO 300 Oral Suspension; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy

Interventions

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.

Also known as: genistein, 5, 7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one

Single-arm

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.

Also known as: Onxol, Taxol

Single-arm

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.

Also known as: Paraplatin, CARBOplatin Novaplus

Single-arm

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.

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Humanetics Corporation: lead
• National Cancer Institute (NCI): collaborator
• Henry Ford Health System: collaborator
• Medical College of Wisconsin: collaborator
• University of Maryland, Baltimore: collaborator
• Milwaukee VA Medical Center: collaborator

Study Sites (4)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (2)

• 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.

  PMID: 37652301 BACKGROUND

• 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.

  PMID: 28489488 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Genistein; Paclitaxel; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Therapeutics

Results Point of Contact

• Title: Michael D. Kaytor
• Organization: Humanetics Corporation

mkaytor@humaneticscorp.com

952-400-0406

Study Officials

• Michael D. Kaytor, PhD

  Humanetics Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: October 5, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2020
• Last Updated: January 25, 2024
• Results First Posted: December 20, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)