BIO 300 Non-Small Cell Lung Cancer Study

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

Interventions

DRUG

BIO 300 Oral Suspension

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.

DRUG

Paclitaxel

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.

DRUG

Carboplatin

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.

RADIATION

Radiotherapy

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Henry Ford Health System

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• University of Maryland, Baltimore

  collaborator OTHER

• Milwaukee VA Medical Center

  collaborator FED

• Humanetics Corporation

  lead INDUSTRY

Principal Investigators

• Michael D. Kaytor, PhD · Humanetics Corporation

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2019-04-30

Completion

2020-09-30

Countries

• United States

Study Locations