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A 24-week, Open-label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A 24-week, Open-label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma


The main objective of this study is to assess the long-term efficacy of SCIO-469 as
monotherapy, or in combination with bortezomib in relapsed, refractory patients with
multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003
study. Patients took by mouth two capsules (60 mg) three times a day alone or in combination
with bortezomib, for 168 days.


Inclusion Criteria:



- Patients who did not have disease progression on Day 73 of Study B003

- patients fully understand all elements of, and have signed and dated, the written
Informed Consent Form (ICF) before initiation of protocol-specified procedures

Exclusion Criteria:

- Patients who have an active uncontrolled infection

- any condition, including laboratory abnormalities, that in the opinion of the
investigator places the patient at unacceptable risk to participate in the study

- pregnant or lactating women, or who are not using adequate contraception

- sexually active women of childbearing potential (WCBP) who do not agree to use at
least two forms of medically accepted birth control, including one barrier method,
for the duration of the study

- men who do not agree to use an acceptable method for contraception throughout the
study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.

Outcome Time Frame:

Baseline to Day 168

Safety Issue:

No

Principal Investigator

Scios, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Scios, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CR005182

NCT ID:

NCT00095680

Start Date:

November 2004

Completion Date:

February 2006

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • SCIO-469
  • Bortezomib
  • p38 MAP kinase
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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