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New treatment option for Gastrointestinal Stromal Tumor (GIST)
Official title A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
ClinicalTrials.gov ID: NCT06655246
What this study is testing
What is ziftomenib?
ziftomenib is an investigational medicine, 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
- In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
- Phase 1: an early, usually small safety study
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
- Documented diagnosis of advanced/metastatic KIT-mutant GIST.
- Documented disease progression on imatinib as current or prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.
- At least 1 measurable lesion per RECIST v1.1 modified for GIST.
- Negative pregnancy test for participants of childbearing potential.
You likely can't join if
- Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.
- History of prior or current cancer that has potential to interfere with obtaining study results.
- Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study...
- Active central nervous system metastases.
- Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
- Mean corrected QT interval (QTcF) greater than 470ms.
See the full eligibility criteria
- Documented diagnosis of advanced/metastatic KIT-mutant GIST.
- Documented disease progression on imatinib as current or prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening.
- At least 1 measurable lesion per RECIST v1.1 modified for GIST.
- Negative pregnancy test for participants of childbearing potential.
- Adequate organ function per protocol requirements.
- Resolution of all clinically significant toxicities from prior therapy to \<Grade 1 (or participant baseline) within 1 week before the first dose of study intervention.
- Participant, or legally authorized representative, must be able to understand and provide written informed consent before the first screening procedure. Key
- Diagnosis of GIST without a KIT mutation or with a T670X KIT mutation.
- History of prior or current cancer that has potential to interfere with obtaining study results.
- Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives before the first dose of study intervention.
- Active central nervous system metastases.
- Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
- Mean corrected QT interval (QTcF) greater than 470ms.
- Left ventricular ejection fraction (LVEF) \<50%.
- Major surgery within 2 weeks before the first dose of study intervention.
- Is pregnant or breastfeeding.
- Gastrointestinal abnormalities that may impact taking study intervention by mouth.
- Actively bleeding, excluding hemorrhoidal or gum bleeding.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
+ 9 more site(s).
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 Birmingham, Alabama, United States; Phoenix, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States and 23 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.