Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma

August 22, 2012 updated by: Cephalon

An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma

An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Emory University Winship Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univeristy Cancer Research Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • The Cancer Center Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

  • Histological and cytological confirmation of stage II or III multiple myeloma.
  • Relapsed or primary refractory multiple myeloma, after 1 or more courses of standard therapy, and progressive disease.
  • ECOG performance status of 0-1.
  • Measurable disease as defined by serum M protein of more than 1.0 gm/dl, serum light chain of more than 200 mg/dL, or Bence-Jones proteinuria of more than 200mg/24 hours.
  • At least 18 years of age.
  • Normal marrow function: ANC>1.0x10 9/L, platelets>50X10 9/L An exception is allowed if myelosuppression or thrombocytopenia is secondary to bone marrow plasmacytosis. Growth factor support is allowed.
  • Normal organ function: bilirubin <1.5XULN, AST and ALT<2XULN, serum creatinine <2.0 mg/dL.
  • Contraceptive measures during participation as appropriate.
  • Willing to be able to comply with study procedures and restrictions.
  • Signed written informed consent.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • Nonsecretory disease or plasma cell leukemia (defined as >2000 circulating plasma cells/uL).
  • More than 4 prior courses if anticancer therapy (bisphosphonates are not considered anticancer therapy for this criterion)
  • Chemotherapy or radiotherapy within 4 weeks prior to enrollment
  • Unresolved adverse events or uncontrolled illness that would be likely to interfere with the objectives of the study.
  • Treatment with an investigational drug within 4 weeks of first day of study treatment
  • History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free more than 5 years).
  • Treatment with potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, and troleandomycin, human immunodeficiency virus (HIV), protease inhibitors, or nefazodone within 1 week (7 days) of the planned 1st day of study treatment.
  • Currently receiving warfarin.
  • Clinical diagnosis of active gastrointestinal ulceration of melena or hematemesis in the previous 4 weeks.
  • Hypersensitivity to CEP701 or any component of CEP701.
  • Intolerance of dexamethasone.
  • Requirement for HIV protease inhibitor treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Investigators

  • Study Director: Peter Brown, Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

October 20, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C0701/2025/ON/US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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