What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as gemcitabine and nab-paclitaxel, are associated with side effects including neutropenia, fatigue, neuropathy, and diarrhea. Temozolomide, another frequently used agent, can cause myelodysplastic syndrome, liver injury, and hematological malignancies. General side effects of chemotherapy include nausea, vomiting, hair loss, and increased risk of infection. Immunotherapy, such as checkpoint inhibitors, can lead to immune-related adverse events like pneumonitis, colitis, and dermatitis. These side effects vary in severity and frequency depending on the specific treatment regimen and patient factors.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of solid tumors, particularly those involving advanced or metastatic stages. For instance, pembrolizumab, an immunotherapy drug, has been approved for various solid tumors, including metastatic melanoma and non-small cell lung cancer, based on its efficacy in improving progression-free survival (PFS) and overall survival (OS). Similarly, nivolumab, another immunotherapy agent, has shown effectiveness in treating advanced renal cell carcinoma and malignant pleural mesothelioma. These approvals often follow rigorous phase trials that evaluate safety, tolerability, and optimal dosing schedules, akin to the ongoing studies for NXP900.

What other types of research exist?

Promising novel alternatives to NXP900 for solid tumor patients include Hsp90 inhibitors, which have shown manageable toxicity and potential clinical activity in metastatic melanoma, prostate cancer, and multiple myeloma. Additionally, immune checkpoint inhibitors such as pembrolizumab and nivolumab, often combined with other agents like chemotherapy or ipilimumab, have demonstrated efficacy in various solid tumors including non-small cell lung cancer, gastric cancer, and renal cell carcinoma.

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NXP900 for Advanced Cancers

Phase 1

Recruiting

Led By Udai Banerji, Prof

Research Sponsored by Nuvectis Pharma, Inc.

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 first dose through day 29

Awards & highlights

Study Summary

This trial tests how safe a drug is when given in higher doses and more often.

Who is the study for?

This trial is for adults with advanced solid tumors that have no effective therapy options or where such treatments are not suitable. Participants must be able to measure their disease, have a good performance status (ECOG 0-1), and agree to use contraception if they can become pregnant. Those with certain types of cancer, recent other treatments, untreated brain metastases, or unresolved major surgery side effects cannot join.Check my eligibility

What is being tested?

The study is testing different doses and schedules of a new drug called NXP900 on patients with various advanced cancers. It's an early-stage trial (Phase 1) focused on finding out the safest dose levels and how often the drug should be given.See study design

What are the potential side effects?

Since this is a Phase 1 trial primarily assessing safety, specific side effects of NXP900 are not yet fully known but may include typical reactions seen in cancer therapies such as fatigue, nausea, inflammation at injection sites among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose through day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose through day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose through day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol

Number of patients with treatment related adverse events and/or clinical laboratory abnormalities

Secondary outcome measures

Apparent plasma clearance at steady state (Clss/F) of NXP900

Apparent volume of distribution at steady state (Vss/F) of NXP900

Area under the concentration-time curve (AUC) of NXP900

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.

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

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways essential for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These mechanisms are vital for solid tumor patients as they offer multiple strategies to control tumor growth, reduce symptoms, and potentially extend survival, while ongoing studies like the NXP900 trial aim to improve the safety and effectiveness of these treatments.

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Who is running the clinical trial?

Nuvectis Pharma, Inc.Lead Sponsor

1 Previous Clinical Trials

61 Total Patients Enrolled

Udai Banerji, ProfPrincipal InvestigatorInstitute of Cancer Research, Royal Marsden NHS Foundation Trust

1 Previous Clinical Trials

61 Total Patients Enrolled

~8 spots leftby Sep 2024

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