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Anti-tumor antibiotic
NEROFE + Doxorubicin for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks until progression, approximately 6 months
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a combination of drugs to treat advanced/metastatic KRAS-mutated and ST-positive tumors. Patients will be given weekly doses to find the best dose and schedule.
Who is the study for?
This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and which have a specific KRAS mutation and ST2 expression. Participants must have tried all standard treatments or chosen not to use them, and should not be pregnant or breastfeeding. They need normal liver function (with some leeway if they have liver metastases), no serious heart conditions, controlled blood pressure, no brain metastases unless treated and stable, and cannot be on certain medications.Check my eligibility
What is being tested?
The study tests the safety of NEROFE combined with doxorubicin in treating solid tumors with specific genetic features. It aims to find the best dose schedule for this combination therapy. Patients will receive weekly doses of both drugs while their health is closely monitored.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, heart problems given doxorubicin's known effect on the heart muscle; plus any additional risks related to NEROFE which are being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks until progression, approximately 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks until progression, approximately 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse events meeting protocol defined dose limiting toxicities
Incidence of Serious Adverse events
Incidence of adverse events
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Pharmacodynamics: Change in KRAS mRNA
+7 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Dose level 2: Nerofe with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 192 mg/m2, intravenously over 60 minutes
Group II: Dose level -1: Nerofe with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 48 mg/m2, intravenously over 60 minutes
Group III: Dose Level 3: Nerofe with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 288 mg/m2, intravenously over 60 minutes
Group IV: Dose Level 1: NEROFE with doxorubicinExperimental Treatment2 Interventions
weekly doses of NEROFE at 96 mg/m2, intravenously over 60 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,478 Total Patients Enrolled
1 Trials studying Tumors
10 Patients Enrolled for Tumors
Immune System Key LtdIndustry Sponsor
4 Previous Clinical Trials
41 Total Patients Enrolled
Benjamin Weinberg, MDStudy ChairGeorgetown University
5 Previous Clinical Trials
173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 9.0 g/dL, possibly after a transfusion.I have Long QT syndrome or a family history of sudden death.I had treatment for brain metastases over 4 weeks ago and my MRI shows no active disease.I understand the study requirements and can follow them.I do not have any severe illness or uncontrolled medical conditions.My condition worsened or I couldn't tolerate standard treatments, but I have no curative options left.I am under 18 years old.I have fully recovered from any side effects of my surgery.I haven't had cancer treatment in the last 3 weeks.I have been treated with anthracycline chemotherapy before.My cancer can be sampled through repeated needle biopsies.I am not pregnant or breastfeeding.I am not on any cancer treatments while in this study.My tumor shows ST2 expression.I do not have serious, uncontrolled heart problems.I haven't had another cancer within the last 2 years, except for certain types.I am currently taking an aromatase inhibitor.I can take care of myself and am up and about more than 50% of my waking hours.My cancer is advanced, cannot be surgically removed, and has a KRAS mutation.I have active hepatitis B, C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1: NEROFE with doxorubicin
- Group 2: Dose level 2: Nerofe with doxorubicin
- Group 3: Dose level -1: Nerofe with doxorubicin
- Group 4: Dose Level 3: Nerofe with doxorubicin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of NEROFE and doxorubicin sanctioned by the Food and Drug Administration?
"Our team's assessment of the safety profile for NEROFE with doxorubicin is a 1 due to this being a Phase 1 trial, which signals that there is only minimal evidence supporting its efficacy and security."
Answered by AI
Is it currently possible for participants to join this experiment?
"As per clinicialtrials.gov, this medical research is not currently recruiting participants; the trial was first published on January 1st 2023 and last updated on December 13th 2022. Despite this inactivity, there are 2623 other studies actively seeking volunteers at present."
Answered by AI
What are the main goals of this experimental research?
"Immune System Key Ltd, the study's sponsor outlines that it is aiming to measure Serious Adverse Events over a period of 6 months starting on Cycle 1 Day 1 and ending 30 days after discontinuation of the medication. Furthermore, secondary objectives include assessing Pharmacokinetic Cmax (maximum 24 hour concentration), Cmin (minimum 24 hours concentration) and Tmax (hour at which Cmax occurs) in patients with advanced KRAS-mutated and ST2-positive solid tumors."
Answered by AI
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