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PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00686842
Recruitment Status : Terminated (Drug supply unavailable.)
First Posted : May 30, 2008
Results First Posted : March 5, 2012
Last Update Posted : September 5, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kaposi's Sarcoma
Interventions: Drug: VEGF inhibitor PTC299
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: biopsy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
VEGF Inhibitor PTC299 Single arm study - all subjects received PTC299

Participant Flow:   Overall Study
    VEGF Inhibitor PTC299
STARTED   17 
COMPLETED   17 
NOT COMPLETED   0 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Safety and Toxicity of Anti-VEGF Small Molecule PTC299   [ Time Frame: All study visits ]

2.  Primary:   Maximum Tolerated Dose   [ Time Frame: After each group of 3 subjects completes cycle 1 of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Primary:   Response to Treatment   [ Time Frame: After each 28-day cycle of treatment and at discontinuation of therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Pharmacokinetics   [ Time Frame: Days 1, 15, 28, 57 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles   [ Time Frame: On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Effects of Study Drug on HIV and KSHV Viral Loads   [ Time Frame: Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8)   [ Time Frame: Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples   [ Time Frame: Screening and day 28 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples   [ Time Frame: Screening and day 28 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information