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Stereotactic Body Radiotherapy (SBRT) for Solid Tumors

Phase 1
Waitlist Available
Led By Adam Olson, MD, MS
Research Sponsored by Luke, Jason, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year (patient), up to 4 years (cohort)
Awards & highlights

Study Summary

This trial will study the combination of SBRT with navoximod and NLG802 to improve response rates to immunotherapy.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year (patient), up to 4 years (cohort)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year (patient), up to 4 years (cohort) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Adverse Events (AE) and Serious Adverse Events (SAE)
Local control by irRECIST
Local control per RECIST version 1.1
+3 more

Side effects data

From 2022 Phase 3 trial • 27 Patients • NCT01926197
100%
Fatigue
100%
Aspartate aminotransferase increased
92%
Diarrhea
92%
Platelet count decreased
83%
Anemia
83%
Weight loss
83%
Alkaline phosphatase increased
83%
Nausea
75%
Pain, abdominal
67%
Decreased appetite (anorexia)
67%
Hypertension
58%
Hyperglycemia
58%
Nerve damage or injury (neuropathy)
58%
Hypokalemia
50%
Alanine aminotransferase increased
50%
White blood cell decreased
50%
Hypoalbuminemia
42%
White blood cell (WBC) count elevated (leukocytosis)
42%
Lymphocyte count decreased
33%
Bloating
33%
Edema, peripheral
25%
Vomiting
25%
Bad taste in mouth (dysgeusia)
25%
Hyponatremia
25%
Anxiety
25%
Pain
25%
Constipation
25%
Hypocalcemia
25%
Labored breathing (dyspnea)
17%
Muscle pain (myalgia)
17%
Indigestion (dyspepsia)
17%
Pain, back
17%
Flatulence
17%
General feeling of discomfort (malaise)
17%
Depression
17%
Hair loss, immune-realted (alopecia)
17%
Neutrophil count decreased
17%
Difficulty sleeping (insomnia)
17%
Oral inflammation (mucositis)
8%
Pain, flank
8%
Other, Creatinine decreased
8%
Lymphedema
8%
Hearing impaired
8%
Bleed (hemorrhage), gastrointestinal
8%
Edema, localized
8%
Thromboembolic event
8%
Allergic reaction
8%
Chills
8%
Fever
8%
Drowsiness, unusual (somnolence)
8%
Tiredness (fatigue)
8%
Muscle weakness lower limb
8%
Abdominal distention
8%
Abnormal sensation in the mouth (oral dysesthesia)
8%
Dry mouth
8%
Gastroesophageal reflux disease
8%
Pain, stomach
8%
Pain, chest, non-cardiac
8%
Lymphocyte count increased
8%
Other, Neutrophil count increase
8%
Other, Protein total decrease
8%
Thrombocytopenia
8%
Weight gain
8%
Hypercalcemia
8%
Hypernatremia
8%
Dizziness
8%
Nerve tingling (paresthesia)
8%
Slow or slurred speech (dysarthria)
8%
Tremor
8%
Rash
8%
Gastroparesis
8%
Flu-like symptoms
8%
Alkaline phosphatase decreased
8%
Blood bilirubin increased
8%
Dehydration
8%
Nerve damage or injury (neuropathy), peripheral sensory
8%
Confusion
8%
Other, axilla boil
8%
Other, hemoglobin decreased
8%
Infusion-related reaction
8%
Arthritis
8%
Generalized muscle weakness
8%
Memory impairment
8%
Movements involuntary
8%
Chronic kidney disease
8%
Cataract
8%
Other, excess in the stool (steatorrhea)
8%
Other, stool discolored, clay color
8%
Gamma-glutamyl transferase (GGT) increased
8%
Hypoglycemia
8%
Urinary incontinence
8%
Urinary urgency
8%
Urine discoloration
8%
Excessive sweating (hyperhidrosis)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Modified FOLFIRINOX
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiotherapy (SBRT) + NLG802 and navoximodExperimental Treatment3 Interventions
SBRT - Initial Starting Dose: Lung - Peripheral - 45 Gy (3 fractions) Lung - Central OR Mediastinal/Thoracic/Axillary/Cervical Lymph Node - 50 Gy (5 fractions) Liver - 45 Gy (3 fractions) Spinal/Paraspinal OR Osseous - 30 Gy (3 fractions) Abdominal/Pelvic (including Adrenal Gland) - 45 Gy (3 fractions) SBRT - Decreased DLT Dose: Lung - Peripheral - 42 Gy (3 fractions) Lung - Central OR Mediastinal/Thoracic/Axillary/Cervical Lymph Node - 47.5 Gy (5 fractions) Liver - 42 Gy (3 fractions) Spinal/Paraspinal OR Osseous - 27 Gy (3 fractions) Abdominal/Pelvic (including Adrenal Gland) - 42 Gy (3 fractions) NLG802 - 1452mg BID (no dose decrease) navoximod - Starting dose: 1000mg BID, Dose decrease 1: 800mg BID, Dose decrease 2: 600mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Luke, Jason, MDLead Sponsor
Lumos PharmaIndustry Sponsor
4 Previous Clinical Trials
182 Total Patients Enrolled
Adam Olson, MD, MSPrincipal InvestigatorUPMC Hillman Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety of Navoximod and NLG802 With Stereotactic Body Radiotherapy (SBRT) Treatment of Advanced Solid Tumors
Adam Olson 2022. "Safety of Navoximod and NLG802 With Stereotactic Body Radiotherapy (SBRT) Treatment of Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469490.
~0 spots leftby Aug 2024
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