Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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)

Protocol: OSU-15172

Full Title

An Open-Label, Multicenter, Global Phase II 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

Purpose

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.

Are you eligible?

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

Breast Cancer Colon Cancer Rectal Cancer Head & Neck Cancers Lymphoma Melanoma Skin Cancers Ovarian Cancer Gynecologic Cancers Brain Cancer Pancreatic Cancer Gastrointestinal Cancers Bladder Cancer Genitourinary Cancers Thyroid Cancer Endocrine Cancers Sarcoma