Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors
Part of paid clinical trials in Fayetteville, Arkansas.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT02703571
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Colorectal Cancer for Phase II
- Pancreatic Cancer for Phase II
- Solid Tumors for Phase Ib
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ribociclib — DRUGCombination treatment with LEE and TMT
- Trametinib — DRUGCombination treatment with LEE and TMT
Study Details
Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.
Key Dates
- Start date
- Jun 29, 2016
- Status verified
- Sep 2020
- Primary completion
- Sep 24, 2019
- Completion
- Sep 24, 2019
Study Design
- Enrollment
- 95 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Advanced or metastatic solid tumorsPatients in the Phase I portion of the study who have advanced or metastatic solid tumors
Primary Outcome Measure
Incidence of dose limiting toxicities (DLTs) [ Time Frame: 21-day cycle one of treatment ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | - |
| City of Hope National Medical Center | Duarte | California | 91010 | - |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | - |
| University of Miami Sylvester Comp Cancer Ctr | Miami | Florida | 33136 | - |
| Dana Farber Cancer Center | Boston | Massachusetts | 02215 | - |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | - |