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Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma

This study has been terminated.
(Drug availability issues)
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00233948
First received: October 5, 2005
Last updated: March 30, 2015
Last verified: March 2015
Results First Received: February 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Liposarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions: Drug: nelfinavir mesylate
Procedure: biopsy
Other: laboratory biomarker analysis
Other: pharmacological study
Genetic: gene expression analysis
Genetic: western blotting
Genetic: reverse transcriptase-polymerase chain reaction
Other: immunoenzyme technique

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase I: Dose Level 1 Oral Nelfinavir at 1250mg bid.
Phase I: Dose Level II Oral Nelfinavir at 1500mg bid.
Phase I: Dose Level III Oral Nelfinavir at 2125mg bid.
Phase I: Dose Level IV Oral Nelfinavir at 3000mg bid.
Phase I: Dose Level V Oral Nelfinavir at 4250mg bid.
Phase II Oral Nelfinavir at 3000mg bid

Participant Flow:   Overall Study
    Phase I: Dose Level 1   Phase I: Dose Level II   Phase I: Dose Level III   Phase I: Dose Level IV   Phase I: Dose Level V   Phase II
STARTED   4   3   3   3   4   12 
COMPLETED   3   3   3   3   4   12 
NOT COMPLETED   1   0   0   0   0   0 
Adverse Event                1                0                0                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
Phase II Oral Nelfinavir at 3000 mg bid
Total Total of all reporting groups

Baseline Measures
   Phase I   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   12   29 
Age 
[Units: Years]
Median (Full Range)
 64 
 (37 to 81) 
 63 
 (46 to 84) 
 64 
 (37 to 84) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   11   6   17 
Region of Enrollment 
[Units: Participants]
     
United States   17   12   29 


  Outcome Measures
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1.  Primary:   Dose Limiting Toxicity (DLT) (Phase I)   [ Time Frame: 4 weeks from start of treatment, up to 2 years ]

2.  Primary:   Maximum Tolerated Dose (MTD) (Phase I)   [ Time Frame: 4 weeks from start of treatment, up to 2 years ]

3.  Primary:   Overall Response Rate (Phase II)   [ Time Frame: After 3 cycles of treatment, up to 2 years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
After 12 patients were accrued to the Phase II portion, the study was terminated…protocol objectives for the Phase II portion not met. Closed prematurely due to drug availability issues.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
phone: 626-256-4673 ext 65265
e-mail: pfrankel@coh.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00233948     History of Changes
Other Study ID Numbers: 04090
NCI-2010-01263
CDR0000438712 ( Registry Identifier: PDQ )
FDA R01FD003006-03 ( Other Identifier: FDA Office of Orphan Products Development )
Study First Received: October 5, 2005
Results First Received: February 2, 2015
Last Updated: March 30, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board