Skip to main content
OpenTrials
Completed

NCT Number: NCT00661180

Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec

The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006, in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of the standard medication administered for these patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Myelogenous Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Have Philadelphia chromosome positive chronic myelogenous leukemia (CML) in chronic phase, as per IBMTR criteria- Have documented hematologic resistance to Gleevec (Imatinib) following a prior hematologic response to Gleevec administered at doses of at least 400 mg/d for at least 3 months.- Have WBC >20 x 109/L at study entry- Have an ECOG performance status. Status of 0, 1 or 2- Have an anticipated survival of at least 16 weeks.- Be able to comply with study procedures and follow-up examinations.- Signed informed consent must be obtained prior to any study specific procedures. Exclusion Criteria:- Congestive heart failure > class II as defined by the New York Heart Association Functional Classification (NYHA)- Cardiac arrhythmias requiring antiarrythmics (excluding beta blockers or digoxin)- Active coronary artery disease or ischemia- History of HIV infection or chronic hepatitis B or C - Active clinically serious infections (> grade 2 NCI-CTC)- Patients with seizure disorder requiring anti-epileptic drugs- History of solid organ allograft

Treatment and study plan

Nexavar (Sorafenib, BAY43-9006)

Drug

Patients will receive Bay 43-9006 400 mg po twice daily in a continuous, uninterrupted schedule. Treatment will continue until there is objective evidence of disease progression, or until evidence of toxicities that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.

Primary outcomes

  1. To determine the major hematologic response rate (i.e. complete and partial hematologic responses) associated with BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.

    Time frame: Every 3 months

Secondary outcomes

  1. To determine the cytogenetic response rate associated with BAY 43-9006.

    Time frame: Every 3 months

  2. To evaluate the duration of hematologic response to BAY 43-9006.

    Time frame: Throughout study until end of response

  3. To evaluate the duration of cytogenetic response to BAY 43-9006.

    Time frame: Throughout study until end of response

  4. To assess time to progression.

    Time frame: Until event occurs

  5. To assess overall survival..

    Time frame: During Follow up

  6. To evaluate the molecular response and to perform the pharmacodynamic assessment by analysis the following biomarkers: phospho-Erk, Crkl, phospho-S6

    Time frame: At 2 months and at last visit

  7. To assess the safety of BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.

    Time frame: Ongoing

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)

Acronym: ORACLE

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 18, 2008
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.