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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)

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ClinicalTrials.gov Identifier: NCT02568267
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ignyta, Inc.

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.

Condition or disease Intervention/treatment Phase
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 Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: NTRK1/2/3-rearranged NSCLC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: ROS1-rearranged NSCLC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: ALK- or ROS1-rearranged NSCLC

with CNS-only progression previously treated with crizotinib

Oral entrectinib (RXDX-101)

Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: NTRK/1/2/3-rearranged mCRC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: ROS1-rearranged mCRC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: ALK-rearranged mCRC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: NTRK1/2/3-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: ROS1-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101
Experimental: ALK-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101



Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568267


Contacts
Contact: Ignyta Inc. 1-844-782-7875 STARTRKtrials@ignyta.com

  Show 154 Study Locations
Sponsors and Collaborators
Ignyta, Inc.
Investigators
Study Director: Edna Chow Maneval, PhD Ignyta, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ignyta, Inc.
ClinicalTrials.gov Identifier: NCT02568267     History of Changes
Other Study ID Numbers: RXDX-101-02
2015‐003385‐84 ( EudraCT Number )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by Ignyta, Inc.:
Entrectinib
RXDX-101
TrkA
TrkB
TrkC
NTRK1
NTRK2
NTRK3
ROS1
ALK
Trk Fusions
NTRK Gene Rearrangements
ROS1 Fusions
ROS1 Gene Rearrangements
ALK Fusions
ALK Gene Rearrangements
Basket study
Non-small cell lung cancer
Colorectal cancer
Salivary gland cancers
Primary brain tumors
Melanoma
Sarcomas
Papillary thyroid cancer
Renal cell cancer
Pancreatic cancer
Breast cancer
Cholangiocarcinoma
Head & Neck cancers
Ovarian cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Colorectal Neoplasms
Pancreatic Neoplasms
Sarcoma
Ovarian Neoplasms
Carcinoma, Renal Cell
Brain Neoplasms
Thyroid Neoplasms
Neuroendocrine Tumors
Cholangiocarcinoma
Salivary Gland Neoplasms
Head and Neck Neoplasms
Carcinoma
Lymphoma, Large-Cell, Anaplastic
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms