| ClinicalTrials.gov Identifier |
| NCT04383210 |
| Institution Name |
| Sarah Cannon Research Institute |
| Institution Address (Street) |
| 250 25th Ave. North |
| Institution City |
| Nashville |
| Institution State |
| Tennessee |
| Institution ZIP Code |
| 37203 |
| Institution Country |
| United States |
| Institution Phone |
| (716) 371-1125 |
| Institution Website |
| http://www.nrg1fusion.com |
| Additional Institutions |
- Sarah Cannon /HCA Research Institute
- VA Cancer Specialists – USOR
- MD Anderson Cancer Center
- Massachusetts General Hospital
- Cedars-Sinai Medical Center
- University of California - Irvine
- University of Colorado Denver
- Northwestern University
- Levine Cancer Institute
- Washington University School of Medicine
- Henry Ford Health System
- University of Wisconsin - Carbone Cancer Center
- AdventHealth Orlando
- Scottsdale Healthcare Hsps DBA HonorHealth
- Montefiore Medical Center
- Compassionate Cancer Care Med Grp - Fountain Valley
- Northwest Medical Specialists, PLLC (NWMS)
- Utah Cancer Specialists
|
| Principal Investigator |
| Elevation Oncology, Inc. |
| Principal Investigator Phone |
| (716) 371-1125 |
| Principal Investigator Email |
| clinical@elevationoncology.com |
| Additional Principal Investigators |
| Current and open site PIs: Drs. David Spigel/Johanna Bendell (SCRI), Yasir Elamin (MDACC), Jessica Lin/Sam Klempner (MGH), Karen Reckamp (Cedars), Viola Zhu/Ignatius Ou (UC-Irvine), Tejas Patil/Ross Camidge (UC-Denver), Young Chae (Northwestern University), Daniel Carrizosa (Levine Cancer), Saiama Waqar/Kian-Huat Lim (Wash U), Shirish Gadgeel (HFHS), Mark Burkard/Noelle (Carbone-U of WI), Mark Socinski (AdventHealth), Frank Tsai/Erkut Borazanci (Honor Health-Scottsdale), Balazs Halmos (Montefiore), Alexander Spira/Robert Coleman (VA Cancer Specialists/USOR), Jhangiani (Compassionate Care - Fountain Valley, CA), Frank Senecal (NW Specialties- Tacoma, WA), Kendall (Utah); At least 10 sites in study start up and expansion ex-US in progress |
| Study Coordinator |
| Clinical Operations/Medpace |
| Study Coordinator Phone |
| (716) 371-1125 |
| Study Coordinator Email |
| clinical@elevationoncology.com |
| Study Overview |
| CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received. |
| Enrollment Information |
| 75 |
| Study Start Date |
| 20200717 |
| Study End Date |
| 20230630 |
| Study Purpose |
- The primary objective of this study is to determine the overall objective response rate (ORR) by independent review to single agent seribantumab in patients with NRG1 gene fusion positive advanced cancer according to RECIST 1.1
|
| Inclusion Criteria |
- NRG1 gene fusion from biomarker test: Locally-advanced or metastatic solid tumor with an NRG1 gene fusion identified through molecular assays, such as PCR, NGS (RNA or DNA) or FISH, by a CLIA-certified or similarly accredited laboratory
- Patients should have received a minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies, with no further available curative therapy options
- Patients must have at least one measurable extra-cranial lesion as defined by RECIST v1.1
|
| Exclusion Criteria |
- Known, actionable oncogenic driver mutation other than NRG1 fusion where available standard therapy is indicated
- Symptomatic or untreated brain metastases (Note: Patients with asymptomatic brain metastases treated with radiation or surgery and without evidence of progression by imaging at screening are eligible to participate in the study. Patients requiring ongoing corticosteroids to treat brain metastases will not be eligible).
|
| Required Tests Prior to Study |
- Biomarker testing from a CLIA approved lab that identifies the tumor has a NRG1 gene fusion
|
| Potential Side Effects |
- Fatigue
- Nausea
- Diarrhea
- Rash
|
| Financial Assistance Available |
| No |
