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Phase I (Dose Escalation with Backfilling) for Pancreatic Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Ipsen

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 at end of treatment (up to approximately 32 months)

Awards & highlights

Study Summary

"This trial aims to find out the right amount of the drug IPN01194 for adults with advanced solid tumors. Participants in the study will have cancers that have spread to nearby tissues or other parts of

Who is the study for?

Adults over 18 with advanced solid tumors like melanoma, colorectal cancer, pancreatic cancer, or head and neck squamous cell carcinoma can join. They must have specific genetic mutations (MAPKm), measurable disease by RECIST criteria, and be in good physical condition (ECOG/PS of 0 or 1). No other effective standard treatments should be available for them.Check my eligibility

What is being tested?

The trial is testing IPN01194's correct dosage, safety, and effectiveness when taken orally by adults with advanced solid tumors. All participants will receive the study drug to see how well it works against their cancers.See study design

What are the potential side effects?

While the exact side effects are not listed here, common ones for cancer drugs include nausea, fatigue, diarrhea, risk of infection due to lowered immunity; skin changes; and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of treatment (up to approximately 32 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of treatment (up to approximately 32 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of treatment (up to approximately 32 months) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)

Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations

Phase 1: Percentage of participants with dose limiting toxicity (DLT)

+1 more

Secondary outcome measures

Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194

Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state

Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase IIa (Cohort Expansion)Experimental Treatment1 Intervention

Study intervention will be administered at one of two doses of interest determined at the end of Phase I.

Group II: Phase I (Dose Escalation with Backfilling)Experimental Treatment1 Intervention

Nine dose levels are planned to be tested.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor

346 Previous Clinical Trials

73,081 Total Patients Enrolled

Ipsen Medical DirectorStudy DirectorIpsen

258 Previous Clinical Trials

55,070 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 available vacancies for participants in this clinical trial?

"Indeed, information on clinicaltrials.gov confirms that this investigation is currently in pursuit of suitable candidates. The trial was initially disclosed on March 15th, 2024, and last revised on March 20th, 2024. A total of 220 participants are being sought from one designated site."

Answered by AI

What is the current size of the patient cohort being observed in this clinical investigation?

"Indeed, as per clinicaltrials.gov, this specific trial is actively seeking individuals to participate. Initial posting of the trial was on March 15th, 2024 and it underwent its latest update on March 20th, 2024. Recruitment aims at enrolling a total of 220 participants at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

2024. "A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305247.

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