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Combined Oral and IV Chemotherapy for Advanced or Metastatic Solid Tumors
Sonia Ali, MD
This is a Phase 2 study to assess the safety and preliminary effectiveness of an investigational anti-cancer medication, rebastinib, combined with a current approved medication, paclitaxel, in patients with advanced or metastatic solid tumors. This is an open-label study which means you will know which drugs you are receiving. All treatments and physician visits during this study will take place at Scripps Clinic Torrey Pines.
Be 18 years of age or older
Have a confirmed diagnosis of a locally advanced or metastatic solid tumor
Be eligible to receive paclitaxel chemotherapy
Have cancer that has progressed, despite standard therapies
Agree to contraception requirements through 120 days following last dose
Meet all other eligibility criteria
Have received prior systemic anti-cancer treatment within 28 days
Be pregnant or lactating, or expecting to conceive or father children within the defined study duration
Have other significant medical conditions that would interfere with the study, in the physician’s opinion
Rebastinib is an inhibitor of a molecule that acts in cancer growth and cancer cell survival, called “TIE2”. Paclitaxel is approved by the FDA as single therapy and in combination with other chemotherapy medications in a variety of cancer types. The dosage of rebastinib being administered is based on safety data from the prior cohorts of patients in part 1b of this study.
Rebastinib will be taken orally twice daily. Paclitaxel will be given intravenously in the clinic on Days 1, 8, and 15 of each 28 day cycle.
Patients will receive study treatment until they develop progressive disease, experience unacceptable toxicity, or withdraw from the study.