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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)

This study is currently recruiting participants.
Verified October 2017 by Ignyta, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02568267
First Posted: October 5, 2015
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Ignyta, Inc.
October 2, 2015
October 5, 2015
October 12, 2017
October 2015
October 2017   (Final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Approximately 24 months ]
Assessed by blinded independent central review (BICR) using RECIST v1.1
Same as current
Complete list of historical versions of study NCT02568267 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
  • 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

    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2018
October 2017   (Final data collection date for primary outcome measure)

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
  • Incomplete recovery from any surgery
  • History of non-pharmacologically induced prolonged QTc interval
  • History of additional risk factors for torsade 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Ignyta Inc. 1-844-782-7875 STARTRKtrials@ignyta.com
Australia,   Belgium,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
 
 
NCT02568267
RXDX-101-02
2015‐003385‐84 ( EudraCT Number )
Yes
Not Provided
Not Provided
Ignyta, Inc.
Ignyta, Inc.
Not Provided
Study Director: Edna Chow Maneval, PhD Ignyta, Inc.
Ignyta, Inc.
October 2017

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