This is a multicenter study that will initially be conducted at 1 to 3 sites in the US. If appropriate, the number of sites may be expanded to include up to approximately 30 sites in total, including expansion into other global regions.
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Study Phase: Phase III
Research Hypothesis: Oral or enteric administration of prophylactic apixaban during induction chemotherapy will reduce the risk of venous thromboembolism (symptomatic + asymptomatic), compared to no systemic anticoagulant prophylaxis, during induction chemotherapy in children with newly diagnosed acute lymphoblastic leukemia (ALL)
or lymphoma (T or B cell) with central venous line treated with PEG L-asparaginase.
Treatment with apixaban will begin between Days 1 to 4 and stop on Day 28 of induction chemotherapy. During the study, the Apixaban treatment will be held at least 12 - hours prior to any planned lumbar puncture (LP) and resumed no sooner than 18-24 hours after the procedure. In the event of a traumatic lumbar puncture (defined in this protocol as a lumbar puncture with >= 10 red blood cells (RBCs)/uL of cerebrospinal fluid (CSF), apixaban should be held for 48 hours after the procedure.
The purpose of this study is to evaluate the efficacy and safety of BGB-A317 as second line treatment in patients with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.
This is a Phase 2, randomized, international, multi-center, double-blinded study of ONT-380 or placebo in combination with capecitabine and trastuzumab in patients with progressive, unresectable locally recurrent or metastatic HER2+ breast cancer who have had prior treatment with a taxane, trastuzumab, pertuzumab, and T-DM1. After signing informed consent and meeting all eligibility criteria (including assessments based on screening MRI), patients will be randomized in a 2:1 ratio using a dynamic hierarchical randomization scheme to receive ONT-380 or placebo in combination with capecitabine and trastuzumab. Stratification factors will include known history of treated or untreated CNS metastases (yes/no), ECOG PS (0 vs. 1), and region of world (US vs. Canada vs. Western Europe). Stratification for presence of CNS metastases will be based upon investigator assessment of screening MRI. Treatment will be administered in cycles of 21 days each. ONT-380 300 mg or placebo will be given orally twice daily (PO BID). Capecitabine will be given at 1000 mg/m2 PO BID on Days 1 14 of each 21-day cycle. Trastuzumab will be given as a loading dose of 8 mg/kg intravenously (IV) followed by 6 mg/kg once every 21 days, except in specific circumstances where it may be given weekly to compensate for modifications in treatment schedule. Dose modifications of ONT-380 or placebo and capecitabine will be allowed. Treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. In the absence of clear evidence of clinical or radiographic progression, development of CNS symptoms, or radiographic changes thought to pose potential immediate risk to the patient, all efforts should be made to continue treatment until unequivocal evidence of radiologic or clinical progression occurs. No crossover from placebo to ONT-380 will be allowed. However, patients assessed as having CNS progression per the RANO-BM criteria, but without having non-CNS progression per the RECIST 1.1 criteria, may be eligible to continue on study treatment after undergoing local therapy to CNS disease, with approval from the medical monitor, until non-CNS progression or second CNS progression.
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Creatine is one of the most studied supplements with research demonstrating its efficacy in augmenting training adaptations such as improved strength and physical function in a variety of healthy and clinical populations. Given the additive effects of creatine and exercise improving muscle performance and lean body mass, it is not surprising that creatine is being explored as a cancer therapeutic to improve survivorship. However, the paucity of research in this area stems from the lack of awareness of the potential role of creatine supplementation in cancer survivors. Therefore, the purpose of this project is to test the hypothesis that creatine will accelerate adaptations associated with exercise in cancer survivors that are engaged in the Thrivewell exercise program.