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Voreloxin Trials
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Voreloxin in Phase 1 and 2 Clinical Trials

Phase 2 Study: REVEAL-1 (Response Evaluation of VorEloxin in AML)
Status: Closed
Focus: Leukemia

The Phase 2 REVEAL-1 study of voreloxin will evaluate the safety and anticancer activity of voreloxin as a treatment for patients over 60 years of age with previously untreated acute myeloid leukemia unlikely to benefit from standard chemotherapy induction. This open label, multicenter trial is currently enrolling patients.

Acute myeloid leukemia is a blood cancer that is mostly seen in older patients (most patients are over the age of 60). The standard treatment for patients would include a class of drugs known as anthracyclines (such as daunorubicin) and a class of drugs known as nucleoside analogues (such as cytarabine). Older patients with leukemia typically do not respond as well to this therapy compared to younger patients for a number of reasons such as their overall health and the nature of the disease.

The unique identifier for this study on ClinicalTrials.gov is SPO-0014.

Phase 1b/2 Study
Status: Closed
Focus: Leukemia

This is a Phase 1b/2study of voreloxin in combination with cytarabine as a treatment for patients with relapsed/refractory acute myeloid leukemia. The study currently is enrolling patients.

AML patients with relapsed or refractory disease have very few treatment options. Single agent cytarabine is the current treatment standard for relapsed AML patients dosed across a range of different dose levels administered by either bolus infusion or 24 hour continuous infusion with typical remission rates of approximately 20 percent.

The unique identifier for this study on ClinicalTrials.gov is SPO-0012.

Phase 2 Study
Status: Closed
Focus: Ovarian Cancer

This study is for voreloxin as a treatment for women 18 years or older with ovarian cancer who previously have received treatment with a platinum-based chemotherapeutic drug regimen and either did not respond to platinum-based therapy or relapsed within 6 months of their initial response to platinum-based therapy.

Ovarian cancer is a disease that forms in the tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells). The American Cancer Society estimates that more than 21,000 women will be diagnosed with ovarian cancer in the United States this year. After an initial response to therapy, recurrence rates are unfortunately very high, in spite of advances in cancer treatment.

The unique identifier for this study on ClinicalTrials.gov is SPO-0010.

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