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Trial record 5 of 6 for:    ONCOS-102

ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers

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: NCT01598129
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : October 2, 2014
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Targovax ASA ( Targovax Oy )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Solid Tumour
Intervention Genetic: ONCOS-102
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CGTG-102
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CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Period Title: Overall Study
Started 12
Completed 3
Not Completed 9
Reason Not Completed
Disease progression             6
Deterioration of WHO status to WHO 4             2
Withdrawal by Subject             1
Arm/Group Title CGTG-102
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CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
63
(38 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 12 participants
12
Number of cancer indications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
9
1.Primary Outcome
Title Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGTG-102
Hide Arm/Group Description:

CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
12
2.Primary Outcome
Title Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities
Hide Description No Dose Limiting Toxicities were observed at any dose level.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGTG-102
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CGTG-102 dose escalation

ONCOS-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Dose limiting toxicities
0
3.Secondary Outcome
Title To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.
Hide Description Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.
Time Frame 12 months
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Number of Participants With Stable Disease Status as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Evaluation Three Months After Starting CGTG-102 Treatment.
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGTG-102
Hide Arm/Group Description:

CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
4
5.Other Pre-specified Outcome
Title Quality of Life Using EORTC QLQ-C30.
Hide Description To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.
Time Frame 12 months
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.
Hide Description [Not Specified]
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGTG-102
Hide Arm/Group Description:

CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
12
7.Other Pre-specified Outcome
Title Number of Participants With Infiltration of CD8+ T Cells Into Tumors.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGTG-102
Hide Arm/Group Description:

CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
11
8.Other Pre-specified Outcome
Title Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CGTG-102
Hide Arm/Group Description:

CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
2
Time Frame Patients were followed up for Adverse Events throughout the study.
Adverse Event Reporting Description There was no indication of a relationship between dose of CGTG-102 and the incidence or intensity of Adverse Events.
 
Arm/Group Title CGTG-102
Hide Arm/Group Description

CGTG-102 dose escalation

CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.

All-Cause Mortality
CGTG-102
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
CGTG-102
Affected / at Risk (%)
Total   5/12 (41.67%) 
Gastrointestinal disorders   
Duodenal obstruction and small intestinal hemorrhage  1/12 (8.33%) 
Colonic obstruction  1/12 (8.33%) 
Abdominal pain  1/12 (8.33%) 
Hepatobiliary disorders   
Hypoalbuminemia and peripheral oedema  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Muscle rupture  1/12 (8.33%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CGTG-102
Affected / at Risk (%)
Total   12/12 (100.00%) 
Surgical and medical procedures   
Pyrexia  12/12 (100.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Operations
Organization: Oncos Therapeutics
EMail: info@oncos.com
Layout table for additonal information
Responsible Party: Targovax ASA ( Targovax Oy )
ClinicalTrials.gov Identifier: NCT01598129    
Other Study ID Numbers: Oncos-C1
First Submitted: April 19, 2012
First Posted: May 15, 2012
Results First Submitted: June 11, 2014
Results First Posted: October 2, 2014
Last Update Posted: October 24, 2016