What side effects are associated with this type of intervention?

Doxorubicin, a common chemotherapeutic agent, is known for side effects including cardiotoxicity, myelosuppression (neutropenia, anemia, thrombocytopenia), gastrointestinal disturbances (nausea, vomiting), alopecia, and mucositis. While the side effects of NEROFE are not specified, new chemotherapeutic agents often share similar toxicities such as fatigue, gastrointestinal symptoms, and hematologic effects.

What prior FDA approvals exist?

Doxorubicin, an FDA-approved chemotherapeutic agent, is used to treat various cancers such as breast cancer, bladder cancer, Kaposi's sarcoma, lymphoma, and acute lymphocytic leukemia. It works by intercalating DNA and inhibiting topoisomerase II, disrupting DNA replication and transcription. Related drugs include epirubicin and daunorubicin, which have similar mechanisms of action. Combinations of doxorubicin with other agents like ifosfamide have also been approved for enhanced efficacy in treating soft tissue sarcomas and other malignancies.

What other types of research exist?

Promising alternatives to NEROFE and doxorubicin for tumor patients include: 1) Pembrolizumab, an immunotherapy that has shown improved recurrence-free survival in melanoma patients with BRAF V600 mutations. 2) Dabrafenib plus trametinib, a combination therapy targeting BRAF V600 mutations, effective in melanoma and non-small cell lung cancer. 3) Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer and renal cell carcinoma. 4) Regorafenib, a multi-kinase inhibitor, showing efficacy in metastatic osteosarcoma. These therapies offer targeted mechanisms of action and have demonstrated clinical benefits in various cancers.

← Back to Search

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

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of combining NEROFE, a new cancer drug, with doxorubicin, a chemotherapy medication. It focuses on patients with advanced or hard-to-treat solid tumors. NEROFE may help target cancer cells more precisely, while doxorubicin prevents them from multiplying. The goal is to find the best way to use this combination treatment.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks until progression, approximately 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse events meeting protocol defined dose limiting toxicities

Incidence of Serious Adverse events

Incidence of adverse events

Secondary study objectives

Overall Response Rate (ORR)

Overall Survival (OS)

Pharmacodynamics: Change in KRAS mRNA

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~8030

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Doxorubicin, a common treatment for tumors, works by intercalating into DNA and inhibiting topoisomerase II, which disrupts DNA replication and transcription, leading to cancer cell death. This is important for tumor patients as it directly targets and reduces the growth of rapidly dividing cancer cells. Understanding these mechanisms aids in developing effective combination therapies, such as those involving NEROFE and doxorubicin, to improve treatment outcomes and manage resistance.

Anthracycline drug targeting: cytoplasmic versus nuclear--a fork in the road.