Study Name |
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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) |
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NCT02568267 |
Study Center |
Institution Name |
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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 |
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Ignyta Inc. |
City |
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San Diego |
State |
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California |
Zip Code |
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92121 |
Phone |
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(844) 782-7875 |
Website |
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https://www.STARTRKtrials.com/ |
List additional Institutions (include address, phone number, and website) |
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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 |
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Ignyta Inc. |
P.I. Phone |
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(844) 782-7875 |
P.I. Email |
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STARTRKtrials@ignyta.com |
Study Coordinator |
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— |
Study Coordinator Phone |
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(844) 782-7875 |
Study Coordinator Email |
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STARTRKtrials@ignyta.com |
OVERVIEW – in layman’s terms (150 words max) |
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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 |
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Patient enrollment is ongoing. |
Study Start Date |
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09/01/2015 |
Estimated Completion Date |
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12/31/2017 |
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
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- 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.
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Inclusion Criteria – Patients Must: |
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- Please refer to ClinicalTrials.gov identifier NCT02568267 for a complete list of Inclusion Criteria.
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Exclusion Criteria – Patients Must NOT: |
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- Please refer to ClinicalTrials.gov identifier NCT02568267 for a complete list of Exclusion Criteria.
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REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms |
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- Molecular testing of a biopsy sample; evaluation of blood and urine samples to measure your health; CT/MRI scans
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POTENTIAL SIDE-EFFECTS – in layman’s terms |
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- 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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