A Phase 1/2a, Multicenter, Open-Label Study of Oral RXDX-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TrkA, TrkB, TrkC, ROS1, or ALK Molecular Alterations

Ignyta Inc.0 sites83 target enrollmentJuly 4, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Ignyta Inc.
Enrollment: 83
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 4, 2014

End Date

June 2, 2020

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ignyta Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Willing and able to provide written IRB/IEC\-approved Informed Consent.
•2\. Have histologically or cytologically confirmed diagnosis of relapsed or refractory locally advanced or metastatic solid tumors that have a TrkA, TrkB, TrkC, ROS1, or ALK molecular alteration (as defined in Section 7\.1\) and for whom no alternative effective standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
•For Phase 2a: Patients with locally advanced or metastatic solid tumors that have:
•? Cohort \#1: a TrkA molecular alteration.
•? Cohort \#2: a TrkB or TrkC molecular alteration.
•? Cohort \#3: a ROS1 molecular alteration.
•? Cohort \#4a: patients with locally advanced or metastatic solid tumors that have an ALK molecular alteration who are naïve to prior treatment with ALK inhibitors (patients with locally advanced or metastatic non\-small cell lung cancer who have not received prior therapy with crizotinib will be excluded) or who have failed prior treatment with a single ALK inhibitor, including those who did not tolerate crizotinib. If a patient is refractory to one or more ALK inhibitors, then the patient must undergo a tumor biopsy following failure to prior therapy.
•? Cohort \#4b: patients with locally advanced or metastatic solid tumors that have an ALK molecular alteration who have failed prior treatment with more than one ALK inhibitor. If a patient is refractory to one or more ALK inhibitors, then the patient must undergo a tumor biopsy following failure to prior therapy.
•3\. Tumor tissue available for analysis. Only non\-CNS lesions may be re\-biopsied and must incur minimal risk to patients (e.g., percutaneous biopsy).
•4\. Measurable disease according to RECIST version 1\.1\.

Exclusion Criteria

•1\. Current participation in another therapeutic clinical trial.
•2\. Known symptomatic brain metastases or leptomeningeal involvement as assessed by MRI or contrast CT scan examination. Patients with asymptomatic leptomeningeal carcinomatosis may be enrolled at the discretion of the Investigator.
•3\. History of previous cancer, except squamous cell or basal\-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 3 years.
•4\. Incomplete recovery from any surgery prior to treatment.
•5\. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti\-arrhythmic medication.
•6\. History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 450 milliseconds).
•7\. History of additional risk factors for torsade de pointes (e.g., heart failure, family history of long QT syndrome).
•8\. Use of concomitant medications (refer to Section 10 of protocol) that increase or possibly increase the risk to prolong the QTc interval and/or induce torsades de pointes ventricular arrhythmia.
•9\. Known active infections (bacterial, fungal, viral including HIV positivity).
•10\. Gastrointestinal disease (e.g., Crohn?s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.