BridgeMD
New treatment option for Gastrointestinal Stromal Tumor (GIST)
Official title A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
ClinicalTrials.gov ID: NCT06630234
What this study is testing
What is DCC-3009?
DCC-3009 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastrointestinal stromal tumor (gist).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Module A Part 1 (Escalation):
- Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived...
- Have at least 1 measurable lesion as defined by mRECIST, v1.1
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Adequate organ function, bone marrow function, and electrolytes
You likely can't join if
- Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
- Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
- Has known active central nervous system (CNS) metastases or an active primary CNS cancer
- History or presence of clinically relevant cardiovascular abnormalities
- Major surgery within 28 days of the first dose of study drug
- Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
See the full eligibility criteria
- Module A Part 1 (Escalation):
- Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or...
- Have at least 1 measurable lesion as defined by mRECIST, v1.1
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Adequate organ function, bone marrow function, and electrolytes
- All participants agree to comply with the contraception requirements
- Have a life expectancy of more than 3 months
- Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
- Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
- Has known active central nervous system (CNS) metastases or an active primary CNS cancer
- History or presence of clinically relevant cardiovascular abnormalities
- Major surgery within 28 days of the first dose of study drug
- Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
- Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug
- Known allergy or hypersensitivity to any component of the study drug
- Malabsorption syndrome or other illness that could affect oral absorption
- Any other clinically significant comorbidities
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdate, Arizona, United States
- La Jolla, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdate, Arizona, United States; La Jolla, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Boston, Massachusetts, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.