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NXP800 for Advanced Cancers

Phase 1
Recruiting
Led By Susana Banerjee, Dr
Research Sponsored by Nuvectis Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part B: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Part B: Subjects must have disease progression within 6 months (182 days) from completion of platinum-based therapy (6 months should be calculated from the date of the last administered dose of platinum therapy to the date of radiographic imaging showing progression)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 30 days post last dose of nxp800
Awards & highlights

Study Summary

This trial will test how safe different doses and schedules of NXP800 are.

Who is the study for?
Adults with advanced solid tumors without effective treatment options, or those inappropriate as per the investigator. Specifically for Part B: adults with ARID1a mutated ovarian cancers who've had certain prior treatments and have measurable disease progression. Excludes pregnant/lactating women, men unwilling to prevent pregnancy, and those with recent other treatments or ongoing severe side effects.Check my eligibility
What is being tested?
NXP800 is being tested for safety at different doses/schedules in advanced cancer patients (Part A), and its preliminary efficacy in specific ovarian cancers with ARID1a mutation (Part B). The trial has two phases: dose escalation to assess safety and an expansion phase focusing on efficacy.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to new cancer drugs such as nausea, fatigue, allergic responses, blood count changes, organ inflammation or dysfunction based on similar trials. Specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer worsened within 6 months after finishing platinum-based treatment.
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I've had 1-3 cancer treatments, including one with bevacizumab.
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My ovarian cancer has an ARID1a mutation and is either clear cell or endometrioid type.
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I have a BRCA mutation and have been treated with a PARP inhibitor.
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My cancer is advanced, has spread, and there's no suitable treatment for me.
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I can take care of myself but might not be able to do heavy physical work.
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I can provide a tissue sample for the study, either already collected or by undergoing a biopsy.
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I am 18 years old or older.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 30 days post last dose of nxp800
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 days post last dose of nxp800 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Number of patients with treatment related adverse events, clinical laboratory abnormalities, dose limiting toxicities
Part B: Estimates of disease response by RECIST v 1.1
Part B: Number of patients with treatment related adverse events, and/or clinical laboratory abnormalities.
Secondary outcome measures
Area under the concentration-time curve (AUC) of NXP800
Half-life (T1/2) of NXP800
Maximum observed concentration (Cmax) of NXP800
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part B: Expansion in Ovarian Cancers Cohort 2Experimental Treatment1 Intervention
Subjects will be treated with NXP800 at 75 mg/day.
Group II: Part B: Expansion in Ovarian Cancers Cohort 1Experimental Treatment1 Intervention
Subjects will be treated with NXP800 at 50 mg/day.
Group III: Part A: Dose EscalationExperimental Treatment1 Intervention
Escalating doses of NXP800.

Find a Location

Who is running the clinical trial?

Nuvectis Pharma, Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,578 Total Patients Enrolled
GOG FoundationNETWORK
41 Previous Clinical Trials
16,080 Total Patients Enrolled

Media Library

NXP800 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05226507 — Phase 1
Solid Tumors Research Study Groups: Part B: Expansion in Ovarian Cancers Cohort 2, Part A: Dose Escalation, Part B: Expansion in Ovarian Cancers Cohort 1
Solid Tumors Clinical Trial 2023: NXP800 Highlights & Side Effects. Trial Name: NCT05226507 — Phase 1
NXP800 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226507 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing effort to enlist participants for this scientific experiment?

"This medical study is currently open for recruitment, with the initial post date being December 31st 2021 and final edit occurring August 9th 2022."

Answered by AI

What are the inherent risks associated with NXP800 usage?

"Considering that NXP800 is in the first phase of trials, there is limited evidence to support its safety and efficacy. Thus, our team gave it a score of 1 on a scale from 1 to 3."

Answered by AI

How many participants are taking part in this medical experiment?

"Affirmative. According to the data available on clinicaltrials.gov, this research project is currently in need of participants with 17 individuals being enrolled at a single location since its original posting date of December 31st 2021 and most recent update on August 9th 2022."

Answered by AI
~14 spots leftby Dec 2024