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 (STARTRK-2)

STATUS

Recruiting
End date

Apr 1, 2025
participants needed

700
sponsor

Hoffmann-La Roche

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Updated on 25 October 2022

See if I qualify

lymphoma

small molecule

ROS1

cancer treatment

cancer chemotherapy

solid tumour

solid tumor

targeted therapy

NTRK

crizotinib

proto-oncogene tyrosine-protein kinase ros

leptomeningeal carcinomatosis

gene fusion

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.

Details

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
Treatment	Entrectinib
Clinical Study Identifier	NCT02568267
Sponsor	Hoffmann-La Roche
Last Modified on	25 October 2022

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Eligibility		Yes	No	Not Sure
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
	At least 4 weeks must have elapsed since completion of antibody-directed therapy
	chemotherapy or small molecule targeted therapy
	Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
	Adequate organ function as defined per protocol
	Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
	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
	Familial or personal history of congenital bone disorders, or bone metabolism alterations
	Incomplete recovery from any surgery
	or efficacy
	History of non-pharmacologically induced prolonged QTc interval
	History of additional risk factors for torsades de pointes
	History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study
	Known active infections
	Active gastrointestinal disease or other malabsorption syndromes
	Peripheral neuropathy Grade ≥ 2
	Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
	Other protocol specified criteria

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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 (STARTRK-2)