Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 25, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Entrectinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
- For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
- Measurable or evaluable disease
- Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
- Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements) \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
- At least 4 weeks must have elapsed since completion of antibody-directed therapy
- Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
- Adequate organ function as defined per protocol
- Ability to swallow entrectinib intact
- Other protocol specified criteria
- Current participation in another therapeutic clinical trial
- Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
- History of other previous cancer that would interfere with the determination of safety or efficacy
- Familial or personal history of congenital bone disorders, or bone metabolism alterations
- Incomplete recovery from any surgery
- History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study
- History of non-pharmacologically induced prolonged QTc interval
- History of additional risk factors for torsades de pointes
- Peripheral neuropathy Grade ≥ 2
- Known active infections
- Active gastrointestinal disease or other malabsorption syndromes
- Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
- Other protocol specified criteria
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Dignity Health St Joseph's Hospital and Medical CenterPhoenix, Arizona
- Mayo ClinicPhoenix, Arizona
- City of Hope Cancer CenterDuarte, California
- City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug ServicesDuarte, California
- Scripps ClinicLa Jolla, California
- University of California San Diego Moores Cancer CenterLa Jolla, California
- Southern California Kaiser PermanenteLos Angeles, California
- Univ Of California Irvine College Of MedicineOrange, California
- UCSF Mount Zion Medical CtrSan Francisco, California
- UCSF Mission BaySan Francisco, California
- Sarcoma Oncology CenterSanta Monica, California
- Sarcoma Oncology Research Center LLCSanta Monica, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2026. Always confirm current availability with the study team.