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Tyrosine Kinase Inhibitor

Entrectinib for Solid Tumors (STARTRK-2 Trial)

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable or evaluable disease

Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 36 months

Awards & highlights

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.

Who is the study for?

This trial is for adults with advanced solid tumors that have specific gene rearrangements (NTRK1/2/3, ROS1, or ALK). Participants must have measurable disease, may include those with brain involvement if controlled. They should be past certain treatments by at least 2 weeks and have good organ function. People can't join if they've had certain other cancers, bone disorders, heart failure recently, severe neuropathy, active infections or are in another clinical trial.Check my eligibility

What is being tested?

The study tests Entrectinib's effectiveness on various tumor types with NTRK1/2/3, ROS1 or ALK gene fusions. It's a global Phase 2 trial where patients are grouped based on their tumor type and genetic changes to receive the open-label drug Entrectinib.See study design

What are the potential side effects?

Entrectinib could potentially cause side effects like fatigue, dizziness, taste alteration; constipation or diarrhea; numbness in hands and feet; weight gain; shortness of breath; muscle pain; cognitive changes such as confusion or memory problems.

STARTRK-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured or seen on tests.

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My cancer is advanced and tests positive for specific genetic changes.

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It's been over 2 weeks since my last cancer treatment.

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I can care for myself and doctors expect me to live at least another month.

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I can swallow pills without any issues.

STARTRK-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

Adverse Events

Bone Biomarkers

Bone and Bones

+9 more

Side effects data

From 2019 Phase 1 trial • 28 Patients • NCT03796013

Arthropod bite

Cough

Nasal congestion

100%

80%

60%

40%

20%

Study treatment Arm

Form A Reference Formulation

Form C Test Formulation

STARTRK-2 Trial Design

9Treatment groups

Experimental Treatment

Group I: ROS1-rearranged other solid tumorExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group II: ROS1-rearranged mCRCExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group III: ROS1-rearranged NSCLCExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group IV: NTRK1/2/3-rearranged other solid tumorExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group V: NTRK1/2/3-rearranged NSCLCExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group VI: NTRK/1/2/3-rearranged mCRCExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group VII: ALK-rearranged other solid tumorExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group VIII: ALK-rearranged mCRCExperimental Treatment1 Intervention

Oral entrectinib (RXDX-101)

Group IX: ALK- or ROS1-rearranged NSCLCExperimental Treatment1 Intervention

with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.) Oral entrectinib (RXDX-101)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Entrectinib

2014

Completed Phase 2

~360

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,520 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,968 Total Patients Enrolled

Media Library

Entrectinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02568267 — Phase 2

Head and Neck Cancers Research Study Groups: ROS1-rearranged other solid tumor, ALK-rearranged other solid tumor, NTRK1/2/3-rearranged other solid tumor, ALK-rearranged mCRC, ROS1-rearranged mCRC, NTRK1/2/3-rearranged NSCLC, ROS1-rearranged NSCLC, ALK- or ROS1-rearranged NSCLC, NTRK/1/2/3-rearranged mCRC

Head and Neck Cancers Clinical Trial 2023: Entrectinib Highlights & Side Effects. Trial Name: NCT02568267 — Phase 2

Entrectinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02568267 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI