| 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
|
