Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

Scios, Inc.

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: SCIO-469 and bortezomib; Drug: SCIO-469

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087867

CR005152

SCIO-469MMY2001 (B003)

Details and patient eligibility

About

The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.

Full description

The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Life expectancy more than three months
• diagnosed with multiple myeloma (MM)
• relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
• Karnofsky performance status = 60
• no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
• no history of myocardial infarction within last 6 months
• serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN)
• total serum bilirubin = 2X ULN
• Calculated or measured creatinine clearance >30 mL/min
• platelet count = 30 x 10(9)/L
• hemoglobin concentration = 8 g/dL
• white blood cell count = 2.0 x 10(9)/L

Exclusion criteria

• Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
• major surgery within four weeks of enrollment
• severe elevated serum calcium
• heart failure
• receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
• receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
• known allergies to agents used in bortezomib (e.g., boron or mannitol)
• poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

001

Experimental group

Description:

SCIO-469 two 30-mg capsules three times daily

Treatment:

Drug: SCIO-469

002

Other group

Description:

SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period

Treatment:

Drug: SCIO-469 and bortezomib