Osimertinib and Bevacizumab as Treatment for EGFR-mutant Lung Cancers
Part of paid clinical trials in Basking Ridge, New Jersey.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT02803203
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- EGFR-mutant Lung Cancers
- Non-small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- osimertinib — DRUG
- Bevacizumab — DRUG
Study Details
The purpose of this study is to test the safety of combining the drugs osimertinib and bevacizumab at different dose levels. The investigators want to find out what effects, good and/or bad, taking osimertinib and bevacizumab has on the patient and lung cancer. This study will try to find the best dose of osimertinib and bevacizumab given together that does not cause significant side effects. Once the investigators determine that combining osimertinib and bevacizumab is safe, they want to see if the combination is effective in treating lung cancers with the EGFR mutation.
Key Dates
- Start date
- Jun 29, 2016
- Status verified
- Mar 2022
- Primary completion
- Mar 1, 2022
- Completion
- Mar 1, 2022
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: osimertinib and bevacizumabPhase 1: 3+3 dose escalation design 2 dose levels Dose level -1: Osimertinib 40mg daily Maximum accrual = 12 Bevacizumab 15mg/kg q3 weeks Dose level 1: Osimertinib 80mg daily Bevacizumab 15mg/kg q3 Weeks Phase 2: Use MTD determined during phase 1
Primary Outcome Measure
Osimertinib Maximum Tolerated Dose (MTD) (Phase I) [ Time Frame: 1 year ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memoral Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | - | - |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | - |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | - |
| Memorial Sloan Kettering commack | Commack | New York | 11725 | - |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | - |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | - |
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