Clinical Trial Details

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)

Print record Print record
Trial Information

Broad Health Condition 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

Specific Health Condition
















Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC,

Hospital
Liverpool Hospital
Newcastle Private Hospital
Austin Hospital

Phase of TrialPhase 2

Trial 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.
Eligibility

Key inclusion 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

    -  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

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Hoffmann-La Roche

Trial websitehttps://clinicaltrials.gov/show/NCT02568267

Trial IDNCT02568267