Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02568267

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Adenocarcinoma Adenocarcinoma, Papillary Adnexal Diseases Adult Solid Tumor Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Central Nervous System Diseases Central Nervous System Neoplasms Cholangiocarcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Papillary Thyroid Cancer Primary Brain Tumors Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Cancers Salivary Gland Diseases Salivary Gland Neoplasms Sarcoma Sarcomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomatognathic Diseases Thoracic Neoplasms Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion 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

Treatment and study plan

Entrectinib

Drug

TrkA/B/C, ROS1, and ALK inhibitor

Other names: RXDX-101

Primary outcomes

  1. Objective Response Rate

    Time frame: Approximately 24 months

    Assessed by blinded independent central review (BICR) using RECIST v1.1

Secondary outcomes

  1. Duration of Response

    Time frame: Approximately 24 months

    Assessed by blinded independent central review (BICR) using RECIST v1.1

  2. Time to Response

    Time frame: Approximately 24 months

    Assessed by blinded independent central review (BICR) using RECIST v1.1

  3. Clinical Benefit Rate

    Time frame: Approximately 24 months

    Assessed by blinded independent central review (BICR) using RECIST v1.1

  4. Intracranial Tumor Response

    Time frame: Approximately 24 months

    Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable

  5. CNS Progression-free Survival

    Time frame: Approximately 24 months

    Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable

  6. Progression-free Survival

    Time frame: Approximately 30 months

    Assessed by Kaplan-Meier method

  7. Overall Survival

    Time frame: Approximately 36 months

    Assessed by Kaplan-Meier method

  8. Population PK

    Time frame: Approximately 24 months

    Assessed by Kaplan-Meier method

  9. Adverse Events

    Time frame: Approximately 36 months

    Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE

  10. Quality of Life

    Time frame: Approximately 24 months

    Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively

  11. Bone Growth and Bone Mineral Density

    Time frame: Approximately 30 months

    Assessed with DHA scans

  12. Bone Biomarkers

    Time frame: Approximately 30 months

    Measured by blood

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Acronym: STARTRK-2

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2015
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.