Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma

This study has been terminated.

(Study enrollment was terminated due to a corporate strategic decision unrelated to patient safety.)

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00717522

First received: July 16, 2008

Last updated: March 6, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2008

Last Updated Date

March 6, 2013

Start Date ^ICMJE

August 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs [ Time Frame: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days). ] [ Designated as safety issue: Yes ]

An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.

Original Primary Outcome Measures ^ICMJE

Tumor Response - RECIST [ Time Frame: Every 56 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00717522 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines [ Time Frame: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days). ] [ Designated as safety issue: No ]

Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma

Official Title ^ICMJE

A Phase 2, Multicenter, Open-label, Single Arm, Two-stage Study to Evaluate the Efficacy and Safety of CC-4047 (Pomalidomide) in Patients With Advanced Soft Tissue Sarcomas Who Have Relapsed or Are Refractory to Systemic Anticancer Therapy

Brief Summary

The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Soft Tissue Sarcoma

Intervention ^ICMJE

Drug: Pomalidomide

Other Names:

CC-4047
Pomalyst

Study Arm (s)

Experimental: Pomalidomide

7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle

Intervention: Drug: Pomalidomide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be > 18 years of age
Must have histologically confirmed soft tissue sarcoma
Must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer therapy regimens
Must have measurable or evaluable disease determined as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Must have documented disease progression (PD) determined as per RECIST criteria within 3 months prior to study enrollment
Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

Pregnant or lactating females
Prior therapy with thalidomide or lenalidomide
Prior use of experimental/investigational drug therapy < 3 months prior to treatment initiation
Prior chemotherapy, biologic or immunotherapy < 3 weeks prior to treatment initiation
Prior radiotherapy < 3 weeks prior to treatment initiation
Prior major surgery < 3 weeks prior to treatment initiation
Absolute neutrophil count (ANC) < 1.5 x 109 cells/L
Platelet count < 100 x 109cells/L
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvate transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN) or > 5.0 x ULN in the presence of demonstrable liver metastases
Known active central nervous system (CNS) metastases

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00717522

Other Study ID Numbers ^ICMJE

CC-4047-STSAR-001

Has Data Monitoring Committee

Yes

Responsible Party

Celgene Corporation

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Abderrahim Fandi, MD

Celgene Corporation

Information Provided By

Celgene Corporation

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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