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MAPK Pathway Inhibitor

DCC-3084 Module A Escalation Phase (ModA Part 1) for Melanoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Deciphera Pharmaceuticals LLC

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 start of therapy to death due to any cause (estimated up to 36 months)

Awards & highlights

Study Summary

This trial is testing a new drug called DCC-3084 on its own or with other cancer treatments in people with advanced cancers. It will first focus on patients with solid tumors and may include other

Who is the study for?

This trial is for adults with advanced cancers, including lung cancer, melanoma, and pancreatic cancer that are linked to specific genetic changes in the MAPK pathway. Participants should have a type of tumor or condition like RASopathy or Neurofibromatosis.Check my eligibility

What is being tested?

The study is testing DCC-3084, either alone or with other treatments. It's divided into two parts: first finding the right dose (Dose Escalation), then giving it to more people at this dose (Dose Expansion) to see how well it works and its safety.See study design

What are the potential side effects?

Possible side effects of DCC-3084 may include typical reactions seen with cancer therapies such as nausea, fatigue, skin issues, liver function changes but will be detailed as the trial progresses through phases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of therapy to death due to any cause (estimated up to 36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of therapy to death due to any cause (estimated up to 36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of therapy to death due to any cause (estimated up to 36 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

Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)

Objective Response Rate (ORR) (ModA Part 2)

Secondary outcome measures

ORR (ModA Part 1)

Overall Survival (OS) (ModA Part 1 and 2)

Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: DCC-3084 Module A Expansion Phase (ModA Part 2)Experimental Treatment1 Intervention

Participants will receive DCC-3084 in ModA Part 2, Expansion Phase.

Group II: DCC-3084 Module A Escalation Phase (ModA Part 1)Experimental Treatment1 Intervention

Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Deciphera Pharmaceuticals LLCLead Sponsor

16 Previous Clinical Trials

2,104 Total Patients Enrolled

1 Trials studying Melanoma

323 Patients Enrolled for Melanoma

Frequently Asked Questions

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

Are patients currently able to participate in this ongoing research study?

"According to clinicaltrials.gov, the current trial is not actively seeking participants. It was initially listed on May 1st, 2024 and last revised on February 23rd, 2024. Despite this trial being inactive for recruitment currently, it's noteworthy that there are a substantial number of other trials - precisely 3918 - actively recruiting volunteers at present."

Answered by AI

What are the anticipated results that researchers hope to achieve through conducting this study?

"The main goal of this investigation, to be evaluated over a 28-day Cycle 1 period, is the Objective Response Rate (ORR) (ModA Part 2). Additional measures encompass Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) for ModA in both parts one and two, where Cmax is outlined as described in ModA's first and second sections. Also included are ORR outcomes from ModA part 1 reflecting confirmed complete or partial remission based on specific criteria detailed in the protocol, alongside Progression-Free Survival (PFS) data from both sections of ModA representing the time from"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway

2024. "Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06287463.

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