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This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.
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Inclusion and exclusion criteria
Inclusion Criteria Inclusion criteria must be met at the time of screening unless otherwise specified.
Age ≥ 18 years
Solid Tumor: Histologically documented diagnosis of primary or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists. Entry will include, but is not limited to patients with androgen-independent prostate cancer, and cancers of the breast, ovary, head and neck, non-small cell lung, bladder, colorectal or kidney. Lymphoma: Relapsed or refractory B-Cell, T-Cell or NK-Cell lymphoma or Hodgkin's Disease. At Yale Cancer Center, lymphoma patients will be limited to those who are not eligible for potentially curative re-induction regimens and transplant and without a reasonable chance of having durable remissions with standard therapies.
At least one evaluable lesion. Lesions must be evaluated by CT-scan, MRI, or bone scan. Patients with prostate cancer, bone disease and rising PSA but no other evaluable disease are eligible and will be evaluated based on PSA. For lymphoma patients, lesions can also be measured by PET and/or evaluated in peripheral blood or bone marrow.
Progressive disease: Progressive disease will be defined as new or progressive lesions on CT-scan, MRI, bone scan or by rising PSA (see Section 11.3).
≥ 4 weeks since prior RT or chemotherapy.
Karnofsky Performance Status ≥ 60%
Solid Tumor: Acceptable liver, renal and bone marrow function including the following:
Lymphoma: Acceptable liver, renal and bone marrow function including the following:
Serum potassium within normal range
Estimated life expectancy greater than 3 months
Signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria
Patients who meet any of the following criteria are not eligible to enroll in this trial:
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121 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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