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

Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00242827
• Other study ID #: C0701/2025/ON/US
• Status: Terminated
• Phase: Phase 2
• First received: September 27, 2005
• Last updated: August 22, 2012
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: September 2006
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Oral CEP-701

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	The Cancer Center Hackensack University Medical Center	Hackensack	New Jersey
United States	Indiana Univeristy Cancer Research Center	Indianapolis	Indiana
United States	New York Presbyterian Hospital	New York	New York
United States	Abramson Cancer Center Of University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States,