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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
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 moreTrial 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.
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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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any significant risks associated with the Dose Escalation protocol for patients?
"Our team at Power concluded that the safety of Dose Escalation to be a 1 due to a lack of evidence and data suggesting its efficacy, as this is only in Phase 1 clinical trials."
Answered by AI
Is there currently an opportunity to participate in this experiment?
"As per the information on clinicaltrials.gov, recruitment for this study is still open and has been since October 1st 232023 with most recent updates made a few days later on 4th of that month."
Answered by AI
How many participants have been included in this research project?
"Affirmative. According to the information available on clinicaltrials.gov, this therapeutic trial is actively recruiting patients after being posted on October 1st 2023 and revised most recently on October 4th 2023. The study seeks 40 individuals across a single research site."
Answered by AI
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