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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

Must not have

Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements

Familial or personal history of congenital bone disorders, or bone metabolism alterations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific inhibitors for my cancer due to certain gene changes.

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I have a family or personal history of bone disorders.

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I am still recovering from a recent surgery.

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I have a history of long QT intervals not caused by medication.

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I have risk factors for irregular heartbeats.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I do not have any ongoing infections.

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I have a condition that affects my stomach or intestines' ability to absorb nutrients.

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I have lung scarring or inflammation from previous treatments.

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I have no other cancers that would affect this trial's results.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

Adverse Events

Bone Biomarkers

Bone and Bones

+9 more

Side effects data

From 2021 Phase 1 trial • 38 Patients • NCT04226833

Ventricular extrasystoles

Diarrhoea

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Entrectinib Severe

Entrectinib Moderate

Entrectinib Mild

Entrectinib - Normal

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 15Eligibility criteria met