Trial Title:
A Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies
NCT ID:
NCT05957367
Condition:
GIST
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
DCC-3116
Advanced gastrointestinal stromal tumors
gastrointestinal stromal tumors
ripretinib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DCC-3116
Description:
Oral Tablet Formulation
Arm group label:
Dose Escalation (Part 1, Module A)
Arm group label:
Dose Escalation (Part 1, Module B)
Arm group label:
Expansion (Part 2, Module A)
Arm group label:
Expansion (Part 2, Module B)
Intervention type:
Drug
Intervention name:
Ripretinib
Description:
Oral Tablet Formulation
Arm group label:
Dose Escalation (Part 1, Module B)
Arm group label:
Expansion (Part 2, Module B)
Other name:
QINLOCK, DCC-2618
Summary:
This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a
combination-specific module) study of DCC-3116 in combination with anticancer therapies.
Modules within the master protocol are defined according to different combinations of
DCC-3116 with other anticancer agents.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female ≥18 years of age
- Module A: Part 1 and Part 2:
Module A Part 1 and Part 2 DCC-3116 combination closed on January 8, 2024, with no
participants enrolled.
- Module B: Only for Part 1 (Safety/Dose-finding):
- Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived
growth factor receptor alpha (PDGFRA) mutation
- Must have progressed on at least one approved systemic regimen given in the
locally advanced or metastatic setting or have documented intolerance to it
- Must not have received prior ripretinib treatment
- Module B: Only for Part 2 (Expansion)
- Pathologically confirmed GIST with documented mutation in KIT exon 11
- Must have progressed on imatinib given in the locally advanced or metastatic
setting or have been intolerant to imatinib and may not have received
additional systemic therapy for GIST
- Measurable disease
- Must have a life expectancy of more than 3 months and an ECOG performance status of
0-1
- Adequate organ function and bone marrow reserve based on laboratory assessments
performed at Screening
- Must provide a fresh tumor biopsy and an archival tumor tissue sample, if available
- Must agree to provide an on treatment biopsy
Exclusion Criteria:
- Must not have received the following within the specified time periods prior to the
first dose of study drug:
1. Medications, including anticancer therapies, that are known strong or moderate
inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain
herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the
medication (whichever is longer)
2. Other anticancer therapies and any investigational therapies with a known
safety and PK profile: 14 days or 5×the half-life of the medication (whichever
is shorter)
3. Investigational therapies with unknown safety and PK profile: 28 days. If there
is enough data on the investigational therapy to assess the risk for drug-drug
interactions and late toxicities of prior therapy as low, the Sponsor's Medical
Monitor may approve a shorter washout of 14 days
4. Grapefruit or grapefruit juice: 14 days
- Have not recovered from all clinically relevant toxicities from prior therapy
- New York Heart Association Class III or IV heart disease, active ischemia, or any
other uncontrolled cardiac condition, clinically significant cardiac arrhythmia
requiring therapy, uncontrolled hypertension, congestive heart failure, or
myocardial infarction within 6 months prior to the first dose of study drug
- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal
disease
- Malabsorption syndrome
- Bone disease that requires ongoing treatment or has required treatment within 6
months of signing the informed consent form
- Radiation for indications other than bone disease must have been completed 4 weeks
prior to first dose of study drug, unless it consisted of limited field palliative
radiation, including whole brain radiation, which must have been completed at least
2 weeks prior to first dose of study drug
- Major surgery within 4 weeks of the first dose of study drug
- Active HIV, Hepatitis B or Hepatitis C infection
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California - Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rabia Rehman
Phone:
323-865-3000
Email:
rabia.rehman@med.usc.edu
Investigator:
Last name:
Syma Iqbal, MD
Email:
Principal Investigator
Facility:
Name:
UCLA Department of Medicine-Hematology/Oncology
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jacqueline Banuelos
Phone:
310-869-7014
Phone ext:
16108
Email:
jbanuelosmurillo@mednet.ucla.edu
Investigator:
Last name:
Arun Singh, MD
Email:
Principal Investigator
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nailet Bestard
Phone:
305-243-8173
Email:
nxr518@med.miami.edu
Investigator:
Last name:
Jonathan C Trent, MD, PhD
Email:
Principal Investigator
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julie Burns
Phone:
616-954-5559
Email:
julie.burns@startmidwest.com
Investigator:
Last name:
Sreenivasa Chandana, M.D., Ph.D.
Email:
Principal Investigator
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Phase 1 Screening
Phone:
212-731-5654
Email:
Phase1Screening@nyulangone.org
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Main Campus
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pragya Khadka
Email:
khadkap1@mskcc.org
Contact backup:
Last name:
Melessa Hardayal
Email:
hardayam@mskcc.org
Investigator:
Last name:
Ping Chi, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Taussig Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Answer
Phone:
216-444-7923
Email:
canceranswer@ccf.org
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Knight Cancer Institute Clinical Trials
Phone:
503-494-1080
Email:
trials@ohsu.edu
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Refiola Memushi
Phone:
215-728-3564
Email:
Refiola.Memushi@fccc.edu
Investigator:
Last name:
Margaret von Mehren, MD
Email:
Principal Investigator
Start date:
September 28, 2023
Completion date:
June 2027
Lead sponsor:
Agency:
Deciphera Pharmaceuticals, LLC
Agency class:
Industry
Source:
Deciphera Pharmaceuticals, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957367
