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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) (STARTRK-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568267
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 2, 2015
First Posted Date  ICMJE October 5, 2015
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE November 19, 2015
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
Objective Response Rate [ Time Frame: Approximately 24 months ]
Assessed by blinded independent central review (BICR) using RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • Duration of Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1
  • Time to Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1
  • Clinical Benefit Rate [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1
  • Intracranial Tumor Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
  • CNS Progression-free Survival [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
  • Progression-free Survival [ Time Frame: Approximately 30 months ]
    Assessed by Kaplan-Meier method
  • Overall Survival [ Time Frame: Approximately 36 months ]
    Assessed by Kaplan-Meier method
  • Population PK [ Time Frame: Approximately 24 months ]
    Assessed by Kaplan-Meier method
  • 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
  • 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
  • Bone Growth and Bone Mineral Density [ Time Frame: Approximately 30 months ]
    Assessed with DHA scans
  • Bone Biomarkers [ Time Frame: Approximately 30 months ]
    Measured by blood
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Duration of Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1
  • Time to Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1
  • Clinical Benefit Rate [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1
  • Intracranial Tumor Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RANO-BM
  • CNS Progression-free Survival [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RANO-BM
  • Progression-free Survival [ Time Frame: Approximately 36 months ]
    Assessed by Kaplan-Meier method
  • Overall Survival [ Time Frame: Approximately 36 months ]
    Assessed by Kaplan-Meier method
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Cholangiocarcinoma
  • Colorectal Cancer
  • Head and Neck Neoplasms
  • Lymphoma, Large-Cell, Anaplastic
  • Melanoma
  • Neuroendocrine Tumors
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Papillary Thyroid Cancer
  • Primary Brain Tumors
  • Renal Cell Carcinoma
  • Sarcomas
  • Salivary Gland Cancers
  • Adult Solid Tumor
Intervention  ICMJE Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Study Arms  ICMJE
  • Experimental: NTRK1/2/3-rearranged NSCLC
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: ROS1-rearranged NSCLC
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: ALK- or ROS1-rearranged NSCLC

    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)

    Intervention: Drug: Entrectinib
  • Experimental: NTRK/1/2/3-rearranged mCRC
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: ROS1-rearranged mCRC
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: ALK-rearranged mCRC
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: NTRK1/2/3-rearranged other solid tumor
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: ROS1-rearranged other solid tumor
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
  • Experimental: ALK-rearranged other solid tumor
    Oral entrectinib (RXDX-101)
    Intervention: Drug: Entrectinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2020)
500
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2015)
300
Estimated Study Completion Date  ICMJE December 2, 2024
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    - Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria

  • 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, bone metabolism alterations or osteopenia
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO40782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Japan,   Australia,   Belgium,   China,   France,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568267
Other Study ID Numbers  ICMJE RXDX-101-02
2015-003385-84 ( EudraCT Number )
GO40782 ( Other Identifier: Hoffman-La Roche )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP