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

NCT00717522 | Terminated Phase 2 Results DMC

• 1 other identifier: CC-4047-STSAR-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Soft Tissue Sarcoma

Keywords

Soft Tissue Sarcoma; CC-4047; Pomalidomide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs

  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.

  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).

Secondary Outcomes (1)

• Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines

  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).

Study Arms (1)

Pomalidomide

EXPERIMENTAL

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

Drug: Pomalidomide

Interventions

Pomalidomide DRUG

Also known as: CC-4047, Pomalyst

Pomalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Kootenai Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Associate Director, Clinical Trial Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Abderrahim Fandi, MD

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 17, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 19, 2019
• Results First Posted: April 16, 2013

Record last verified: 2019-11

Locations

US (3)