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Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver

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: NCT00149396
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
MediGene

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Liver Neoplasms
Intervention: Drug: NV1020

  Participant Flow

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
NV1020 Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8

Participant Flow:   Overall Study
    NV1020
STARTED   32 
Completed NV1020 Therapy   29 
Completed NV1020 and Chemotherapy   9 
COMPLETED   9 
NOT COMPLETED   23 
Death                15 
Withdrawal by Subject                1 
Subject noncompliance                2 
other treatment                5 



  Baseline Characteristics

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
NV1020 Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8

Baseline Measures
   NV1020 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.7  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  34.4% 
Male      21  65.6% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   29 
African American   1 
Asian   1 
Hispanic   1 
Carcinoembryonic Antigen (CEA) Level at Screening 
[Units: ng/mL]
Mean (Standard Deviation)
 175.5  (517.4) 
Prior Chemotherapy 
[Units: Participants]
 32 
Karnofsky Performance Status (KPS) [1] 
[Units: Participants]
 
KPS 100   14 
KPS 90   17 
KPS 80   1 
[1]

The KPS was rated as follows:

100 - Normal, no complaints, no evidence of disease; 90 - Able to carry on normal activity; minor signs or symptoms of disease; 80 - Normal activity with effort; some signs or symptoms of disease



  Outcome Measures

1.  Primary:   Incidence of Adverse Events and Dose Limiting Adverse Events   [ Time Frame: From start of treatment through 12 months after completion of treatment ]

2.  Primary:   NV1020 Pharmacokinetics - Presence of NV1020 in Body Fluids/Skin   [ Time Frame: Daily for 2 weeks after the first and last NV1020 infusions ]

3.  Primary:   Clinical Laboratory Safety - Hematology   [ Time Frame: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment ]

4.  Primary:   Clinical Laboratory Safety - Chemistry   [ Time Frame: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment ]

5.  Primary:   Clinical Laboratory Safety - Coagulation   [ Time Frame: Screening; after each NV1020 infusion; +7h, +24h, and +72h after NV1020 infusion; each chemotherapy visit; +3d, +7d, +14d after each chemo visit; 1 week after end of treatment ]

6.  Secondary:   Mean Change From Baseline in Serum Carcinoembryonic Antigen (CEA) After Administration of NV1020 and 2 Cycles of Chemotherapy   [ Time Frame: Screening (baseline), Chemo visit 1, Chemo visit 2, Follow-up Visit 1 (1 week after end of treatment), Follow-up Visit 2 (+6M), Follow-up Visit 3 (+9M), Follow-up Visit 4 (+12M) ]

7.  Secondary:   Liver Tumor Response After Administration of NV1020 Followed by Chemotherapy, Determined by Radiological (Computed Tomography [CT] Scan) Assessment   [ Time Frame: Screening (baseline), Chemo visit 1, Follow-up visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M) ]

8.  Secondary:   Pharmacodynamic Effects of NV1020: NV1020 Neutralizing Antibody Titer Assay   [ Time Frame: Screening, Chemo Visit 1, Follow-up Visits 1 (1 week post end of treatment), 2 (+6M), 3 (+9M), 4 (+12M) ]

9.  Secondary:   Time to Disease Progression; Survival Time   [ Time Frame: Progression: Chemo visit 1, FU1 (1 week post treatment), FU2 (+6M), FU3 (+9M), FU4 (+12M); Survival: death of patient ]

10.  Secondary:   Pharmacodynamic Effects of NV1020: Serum Cytokines (INF Gamma)   [ Time Frame: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7) ]

11.  Secondary:   Pharmacodynamic Effects of NV1020: Serum Cytokines (IL-6)   [ Time Frame: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7) ]

12.  Secondary:   Pharmacodynamic Effects of NV1020: Serum Cytokines (TNF-alpha)   [ Time Frame: Baseline, after each NV1020 infusion (Visit 1, Visit 3, Visit 5, Visit 7) ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director Regulatory Affairs
Organization: Medigene
phone: 858-586-2252
e-mail: p.larson@medigeneusa.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MediGene
ClinicalTrials.gov Identifier: NCT00149396     History of Changes
Other Study ID Numbers: CT1030
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: December 29, 2015
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018