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Entrectinib for Solid Tumors (STARTRK-2 Trial)
STARTRK-2 Trial Summary
This trial is testing a new drug, entrectinib, for patients with different types of solid tumors that have a gene fusion. Patients will be assigned to different groups depending on their tumor type and gene fusion.
STARTRK-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTARTRK-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 trial • 28 Patients • NCT03796013STARTRK-2 Trial Design
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- I have been treated with specific inhibitors for my cancer due to certain gene changes.My cancer can be measured or seen on tests.I finished my radiotherapy more than 14 days ago.My cancer is advanced and tests positive for specific genetic changes.I have a family or personal history of bone disorders.I am still recovering from a recent surgery.I have had heart failure symptoms or a low heart pump function in the last 3 months.I have a history of long QT intervals not caused by medication.I have risk factors for irregular heartbeats.My brain involvement from cancer is either symptom-free or was treated and is now under control.I have lung scarring or inflammation from previous treatments.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have any ongoing infections.I have a condition that affects my stomach or intestines' ability to absorb nutrients.I can provide a tissue sample for testing unless it's medically unsafe for me.I have had cancer treatment but not with Trk, ROS1, or ALK inhibitors for specific gene changes.It's been over 2 weeks since my last cancer treatment.It has been over 4 weeks since my last antibody therapy.I can care for myself and doctors expect me to live at least another month.My organs are working well.I have no other cancers that would affect this trial's results.I can swallow pills without any issues.
- Group 1: ROS1-rearranged other solid tumor
- Group 2: ALK-rearranged other solid tumor
- Group 3: ALK-rearranged mCRC
- Group 4: NTRK1/2/3-rearranged other solid tumor
- Group 5: ROS1-rearranged mCRC
- Group 6: NTRK1/2/3-rearranged NSCLC
- Group 7: ROS1-rearranged NSCLC
- Group 8: ALK- or ROS1-rearranged NSCLC
- Group 9: NTRK/1/2/3-rearranged mCRC
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What health conditions does Entrectinib often treat?
"According to the current medical literature, Entrectinib is an effective therapeutic intervention for diseases, tumors, and other solid conditions."
What other tests or procedures have been done with Entrectinib in the past?
"At this moment in time, there are 18 different clinical trials being conducted to study Entrectinib. Out of those 18, 3 are classified as Phase 3 trials. The majority of these studies are based out of Portland, Oregon; however, there are 1,575 total locations running trials for entrectinib across the globe."
Are patients being accepted into this research program at this time?
"No, this particular trial is not currently looking for new patients. Although it was created on November 19th 2015 and edited as recently as November 14th 2022, there are no plans to recruit at this time. There are, however, 9192 other trials that are presently recruiting candidates."
Is this medical trial novel in its approach?
"As of now, there are 18 ongoing Entrectinib trials in 482 cities and 54 countries. The first drug trial happened in 2015 and was sponsored by Hoffmann-La Roche. It completed its Phase 2 approval stage with the help of 700 participants. In the 6 years since then, 7 more studies have been completed."
What are the potential risks associated with Entrectinib?
"Despite being a Phase 2 trial, meaning that there is only some data supporting safety and none yet for efficacy, our team at Power still gave Entrectinib a score of 2."
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What portion of applicants met pre-screening criteria?
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