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MAPK Pathway Inhibitor
DCC-3084 for Cancer
Phase 1 & 2
Recruiting
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
No Placebo-Only Group
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
Objective Response Rate (ORR) (ModA Part 2)
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
1,861 Total Patients Enrolled
Deciphera Pharmaceuticals, LLCLead Sponsor
18 Previous Clinical Trials
2,017 Total Patients Enrolled