Olaparib With Ceralasertib in Recurrent Osteosarcoma
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT04417062
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Osteosarcoma
- Osteosarcoma Recurrent
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUGOlaparib is taken by mouth, twice daily through out the 28 day study cycle.
- Ceralasertib — DRUGCeralasertib is taken by mouth, twice daily on days 1-14 of the study cycle.
Study Details
This study is being done in order to evaluate the effectiveness of using two drugs (olaparib and ceralasertib) to treat patients with osteosarcoma that has not responded to treatment or has come back after treatment The names of the study drugs involved in this study are: * Olaparib * Ceralasertib
Key Dates
- Start date
- Nov 24, 2020
- Status verified
- Feb 2026
- Primary completion
- Jun 1, 2025
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 63 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Olaparib-CeralasertibUnresectable disease (can not be surgically removed) will be enrolled into Cohort 1 and Resectable disease (can be surgically removed) which is limited only to the lung parenchyma will be enrolled into Cohort 2. * Olaparib at a predetermined dose orally 2 times a day on days 1-28 * Ceralasertib will be given at a predetermined dose orally 2 times a day on days 1-14 in 28-day study cycles. Patients can remain on treatment for up to 2 years if disease progression has not occurred.
Primary Outcome Measure
Cohort 1 Event Free at 4 months [ Time Frame: 4 months after start of protocol therapy ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology | San Francisco | California | 94158 | - |
| Dana Farber Cancer Institite | Boston | Massachusetts | 02115 | - |
| Memorial Sloan Kettering | New York | New York | 10065 | - |
| MD Anderson | Houston | Texas | 77030 | - |
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