STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors (including cholangiocarcinoma) that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors (including cholangiocarcinoma) that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Study Name
STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors(including cholangiocarcinoma) that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
ClinicalTrials.gov Identifier (if applicable)
NCT02568267
Study Center
Institution Name
This is a multicenter, global trial enrolling patients with solid tumors (including cholangiocarcinoma). Please visit www.STARTRKtrials.com, or contact Ignyta at 1-844-STARTRK (782-7875) or via email at STARTRKtrials@ignyta.com to find a participating study center near you.
Institution Address
Ignyta Inc.
City
San Diego
State
California
Zip Code
92121
Phone
(844) 782-7875
Website
https://www.STARTRKtrials.com/
List additional Institutions (include address, phone number, and website)
This is a multicenter, global trial. Please visit www.STARTRKtrials.com, or contact Ignyta at 1-844-STARTRK (782-7875) or via email at STARTRKtrials@ignyta.com to find a participating study center near you.
Study Contacts
Principal Investigator
Ignyta Inc.
P.I. Phone
(844) 782-7875
P.I. Email
STARTRKtrials@ignyta.com
Study Coordinator
Study Coordinator Phone
(844) 782-7875
Study Coordinator Email
STARTRKtrials@ignyta.com
OVERVIEW – in layman’s terms (150 words max)
This study will enroll patients with advanced cancers (including cholangiocarcinoma) that have an NTRK/ROS1/ALK gene rearrangement (also called gene fusions), which may be primary causes of cancer. This study will evaluate if an investigational drug, Entrectinib (also known as RXDX-101), can block the growth of cancer cells caused by NTRK/ROS1/ALK gene rearrangements.
Enrollment
Patient enrollment is ongoing.
Study Start Date
09/01/2015
Estimated Completion Date
12/31/2017
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Gene rearrangements can be detected by a specialized test called molecular testing. Ignyta can assist with this testing or provide information for other labs that can perform this testing.
  • This study will evaluate the safety (side effects) of entrectinib, and evaluate if treatment with entrectinib may slow or stop the growth of solid tumors.
Inclusion Criteria – Patients Must:
  • Please refer to ClinicalTrials.gov identifier NCT02568267 for a complete list of Inclusion Criteria.
Exclusion Criteria – Patients Must NOT:
  • Please refer to ClinicalTrials.gov identifier NCT02568267 for a complete list of Exclusion Criteria.
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Molecular testing of a biopsy sample; evaluation of blood and urine samples to measure your health; CT/MRI scans
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Based on other studies in patients with advanced cancer who have been treated with entrectinib, some common side effects (>10% of patients have experienced) that have been deemed related to entrectinib treatment are: fatigue; loss or change of taste; tingling or prickling sensation of the skin; nausea; pain in muscles/joints; diarrhea; dizziness; vomiting; constipation

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