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Co o rdinating Investigator: Robert Maki, MD, PhD Mount Sinai Medical Center New York, NY

SARC024. A blanket protocol to study oral regorafenib in patients with refractory liposarcoma , osteogenic sarcoma, and Ewing/Ewing-like sarcoma. Co o rdinating Investigator: Robert Maki, MD, PhD Mount Sinai Medical Center New York, NY. SARC024. Co-principal investigators

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Co o rdinating Investigator: Robert Maki, MD, PhD Mount Sinai Medical Center New York, NY

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  1. SARC024 A blanket protocol to study oral regorafenib in patients with refractory liposarcoma, osteogenic sarcoma, and Ewing/Ewing-like sarcoma Coordinating Investigator: Robert Maki, MD, PhD Mount Sinai Medical Center New York, NY

  2. SARC024 • Co-principal investigators • Chris Ryan, MD • Osteosarcoma cohort • Richard Riedel, MD • Liposarcoma cohort • Steven Attia, MD • Ewing/Ewing-like cohort • SARC • Sponsor and coordinating center • Bayer • Supporter

  3. Background • Pazopanib is approved for advanced/metastatic STS other than GIST, liposarcoma • Sorafenib has minor activity in STS in a phase II trial • An Italian report indicates activity of sorafenib in osteosarcoma • Regorafenib is closely related to sorafenib, and is approved 3rd line therapy in metastatic GIST • Regorafenib might be beneficial for other types of sarcoma

  4. SARC024 Cohort Regorafenib Off substudy A Monthly imaging; Crossover at progression Liposarcoma (all subtypes except pure well diffs) R Riedel 1:1 Placebo Regorafenib Off substudy B Monthly imaging; Crossover at progression Osteogenic sarcoma (bone or soft tissue) R 1:1 Ryan Placebo C Ewing/Ewing-like sarcoma (bone or soft tissue) Regorafenib; single stage substudy Attia

  5. SARC024 • Cohort A and Cohort B: • Randomized, double blinded, placebo-controlled, phase II design • n=48 total patients per substudy • Cohort C: • Single stage, single arm phase II design, n=30 • Rx (28 day cycle): regorafenib (± vs placebo), 160 mg oral daily, 3 weeks on, 1 week off • Watch out for toxicity!

  6. Primary Objectives • Cohort A and Cohort B: • Compare the progression-free survival (PFS) of eligible subjects treated with regorafenib vs. placebo • Cohort C: • To estimate the RECIST 1.1 PFS rate of eligible subjects treated with regorafenib at 8 and 16 weeks

  7. Inclusion Criteria • Patients ≥ 18 years old (sorry) • Advanced/metastatic liposarcoma, osteogenic sarcoma, or Ewing/Ewing-like sarcoma of soft tissue or bone histologically or cytologically confirmed • At least one prior line of systemic therapy • WHO performance status of 0-2

  8. Inclusion Criteria • Patient must be able to swallow medication • Adequate organ function within 14 days of registration • Evidence of disease progression (as defined by RECIST 1.1) within 6 months of registration

  9. Study Status • Contracting • In process • Anticipated completion November/December 2013 • Sites • In process of querying sites on interest and capabilities • Activation • Late 2013 / Early 2014

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