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DCC-3116 + Anticancer Therapies for Advanced Cancers
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 approximately 48 months
Awards & highlights
Study Summary
This trial studies how DCC-3116 combined with other cancer treatments affects people with cancer.
Who is the study for?
Adults with advanced colorectal cancer (CRC) having a specific mutation (BRAF V600E), or gastrointestinal stromal tumor (GIST) with certain mutations, who have tried some treatments but not others specified in the study criteria. Participants must be able to provide biopsy samples and have a life expectancy over 3 months.Check my eligibility
What is being tested?
The trial is testing DCC-3116 in combination with other anticancer drugs like Ripretinib, Cetuximab, and Encorafenib. It's an early-stage trial to see how well these combinations work together for treating CRC and GIST.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer therapies such as nausea, fatigue, skin reactions, increased risk of infections due to lowered immunity, liver issues indicated by blood tests changes, and possibly unique side effects related to each drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (Escalation Phase)
Objective response rate (ORR) (Expansion Phase)
Recommended Phase 2 Doses (RP2D) (Escalation Phase)
Secondary outcome measures
Area under the concentration-time curve (AUC)
Disease Control Rate (DCR) (Escalation Phase)
Duration of response (DoR) (Escalation Phase)
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Expansion (Part 2, Module B)Experimental Treatment2 Interventions
DCC-3116 tablets will be administered in combination with ripretinib in 28-day cycles to evaluate preliminary efficacy in participants with 2nd-line advanced gastrointestinal stromal tumor (GIST).
Group II: Expansion (Part 2, Module A)Experimental Treatment3 Interventions
DCC-3116 tablets will be administered in combination with encorafenib and cetuximab in 28-day cycles to evaluate preliminary efficacy in participants with 2nd- or 3rd-line BRAF V600E mutated colorectal cancer (CRC).
Group III: Dose Escalation (Part 1, Module B)Experimental Treatment2 Interventions
DCC-3116 tablets in escalating dose cohorts in 28-day cycles will be administered in combination with ripretinib once daily (QD).
Group IV: Dose Escalation (Part 1, Module A)Experimental Treatment3 Interventions
DCC-3116 tablets in escalating dose cohorts in 28-day cycles will be administered in combination with encorafenib once daily (QD) and cetuximab once every 2 weeks (Q2W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
2021
Completed Phase 3
~960
Ripretinib
2020
Completed Phase 2
~110
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
2,057 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,812 Total Patients Enrolled
Clinical TeamStudy DirectorDeciphera Pharmaceuticals LLC
2 Previous Clinical Trials
377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by tests.My colorectal cancer has a BRAF V600E mutation.I haven't taken strong or moderate drugs affecting CYP3A4 or P-gp, including St. John's wort, recently.I haven't had grapefruit or its juice in the last 14 days.I do not have bone disease needing current or past treatment.I haven't had radiation for reasons other than bone disease recently.I haven't taken any cancer treatments or experimental drugs recently.I haven't had major surgery in the last 4 weeks.I have not been treated with drugs targeting EGFR or BRAF.I have never been treated with ripretinib.My heart is healthy and I haven't had a heart attack in the last 6 months.I have GIST with a confirmed KIT or PDGFRA mutation.My cancer has worsened after treatment, or I couldn't tolerate the treatment.I am expected to live more than 3 months and can care for myself with minimal assistance.I have recovered from major side effects of my previous treatments.I do not have brain metastases or leptomeningeal disease symptoms.I am 18 years old or older.My GIST tumor has a confirmed KIT exon 11 mutation.My cancer got worse on imatinib or I couldn't tolerate it, and I haven't had other treatments for GIST.I do not have a condition that prevents me from absorbing nutrients.My recent tests show my organs and bone marrow are working well.I can provide a new tumor biopsy and an old sample if I have one.I do not have active HIV, Hepatitis B, or Hepatitis C.I've had 1 or 2 treatments for my advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion (Part 2, Module B)
- Group 2: Dose Escalation (Part 1, Module B)
- Group 3: Dose Escalation (Part 1, Module A)
- Group 4: Expansion (Part 2, Module A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open positions for this research project?
"Clinicaltrials.gov currently shows that this trial, initially posted on August 1st 2023, is actively searching for participants and was most recently updated yesterday."
Answered by AI
How many participants are currently enrolled in the experiment?
"Affirmative. According to the clinicaltrials.gov listing, this medical trial is currently recruiting patients and has a total vacancy of 170 people at 1 location since August 1st 2023. The information was most recently updated on August 2nd 2023."
Answered by AI
What are the primary aims of this experimental research?
"The primary purpose of this experiment is to ascertain Recommended Phase 2 Doses (RP2D) over the course of 24 months. Secondary objectives include time to response, overall survival and progression-free survival. These are respectively defined as: time from treatment commencement until first response per RECIST v1.1; period between initiation of therapy and death; interval starting at medication start date till documented disease development or passing, whichever happens earlier."
Answered by AI
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