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

This study has been terminated.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00242827
First received: September 27, 2005
Last updated: August 22, 2012
Last verified: September 2006
  Purpose

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


Condition Intervention Phase
Myeloma
Drug: Oral CEP-701
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Study Start Date: April 2006
Estimated Study Completion Date: May 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242827

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30302
United States, Indiana
Indiana Univeristy Cancer Research Center
Indianapolis, Indiana, United States, 46202
United States, New Jersey
The Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, Pennsylvania
Abramson Cancer Center Of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Peter Brown Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242827     History of Changes
Other Study ID Numbers: C0701/2025/ON/US
Study First Received: September 27, 2005
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014