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Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies

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: NCT00496860
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : July 15, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Altor BioScience

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Progressive Metastatic Malignancies
Intervention Biological: ALT-801
Enrollment 26
Recruitment Details Between 08-2007 and 05-2009, 118 patients were consented and screened, 56 were Human leukocyte antigen (HLA)-A2 positive and had tumor specimens that were positive for target p53 (aa 264-272)/HLA-A*0201 complex. Thirty HLA-A2-positive patients with p53/HLA-A*0201 tumors either withdrew consent or did not meet other inclusion/exclusion criteria.
Pre-assignment Details  
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/ Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description 0.015 mg/kg/dose of ALT-801 0.040 mg/kg/dose of ALT-801 0.080 mg/kg/dose of ALT-801
Period Title: Overall Study
Started 4 16 6
Completed 3 15 6
Not Completed 1 1 0
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose Total
Hide Arm/Group Description 0.015 mg/kg/dose of ALT-801 0.040 mg/kg/dose of ALT-801 0.080 mg/kg/dose of ALT-801 Total of all reporting groups
Overall Number of Baseline Participants 4 16 6 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 16 participants 6 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
15
  93.8%
5
  83.3%
22
  84.6%
>=65 years
2
  50.0%
1
   6.3%
1
  16.7%
4
  15.4%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 16 participants 6 participants 26 participants
65
(50 to 79)
51
(27 to 72)
58
(53 to 65)
54
(27 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 16 participants 6 participants 26 participants
Female
2
  50.0%
6
  37.5%
1
  16.7%
9
  34.6%
Male
2
  50.0%
10
  62.5%
5
  83.3%
17
  65.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 16 participants 6 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   6.3%
0
   0.0%
1
   3.8%
White
4
 100.0%
15
  93.8%
6
 100.0%
25
  96.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies
Hide Description Number of serious adverse events per cohort
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description:
0.015 mg/kg/dose of ALT-801
0.040 mg/kg/dose of ALT-801
0.080 mg/kg/dose of ALT-801
Overall Number of Participants Analyzed 4 16 6
Measure Type: Number
Unit of Measure: Events
0 2 4
2.Primary Outcome
Title The Maximum-tolerated Dose (MTD) of ALT-801
Hide Description Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description:
0.015 mg/kg/dose of ALT-801
0.040 mg/kg/dose of ALT-801
0.080 mg/kg/dose of ALT-801
Overall Number of Participants Analyzed 4 16 6
Measure Type: Number
Unit of Measure: events
0 1 2
3.Secondary Outcome
Title Clinical Antitumor Response to ALT-801
Hide Description Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description:
0.015 mg/kg/dose of ALT-801
0.040 mg/kg/dose of ALT-801
0.080 mg/kg/dose of ALT-801
Overall Number of Participants Analyzed 4 16 6
Measure Type: Number
Unit of Measure: participants
2 5 3
4.Secondary Outcome
Title ALT-801 Induced Cell-mediated Immune Responses
Hide Description Number of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description:
0.015 mg/kg/dose of ALT-801
0.040 mg/kg/dose of ALT-801
0.080 mg/kg/dose of ALT-801
Overall Number of Participants Analyzed 3 16 6
Mean (Standard Error)
Unit of Measure: IFNg spots per million PMBCs
6433  (2847) 9117  (1671) 1125  (163)
5.Secondary Outcome
Title Immunogenicity of ALT-801
Hide Description Titer of anti-drug Abs at week 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description:
0.015 mg/kg/dose of ALT-801
0.040 mg/kg/dose of ALT-801
0.080 mg/kg/dose of ALT-801
Overall Number of Participants Analyzed 3 16 6
Mean (Standard Error)
Unit of Measure: titer
347  (103) 5483  (2310) 762  (97)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Hide Arm/Group Description 0.015 mg/kg/dose of ALT-801 0.040 mg/kg/dose of ALT-801 0.080 mg/kg/dose of ALT-801
All-Cause Mortality
ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      2/16 (12.50%)      4/6 (66.67%)    
Blood and lymphatic system disorders       
Thrombocytopenia  0/4 (0.00%)  0 0/16 (0.00%)  0 1/6 (16.67%)  1
Cardiac disorders       
Cardiac Ischemia/Infarction  0/4 (0.00%)  0 0/16 (0.00%)  0 1/6 (16.67%)  1
General disorders       
Death-NOS  0/4 (0.00%)  0 1/16 (6.25%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion  0/4 (0.00%)  0 1/16 (6.25%)  1 0/6 (0.00%)  0
Pulmonary Infiltrates  0/4 (0.00%)  0 0/16 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders       
THROMBOSIS  0/4 (0.00%)  0 0/16 (0.00%)  0 1/6 (16.67%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALT-801 0.015 mg/kg/Dose ALT-801 0.040 mg/kg/Dose ALT-801 0.080 mg/kg/Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      16/16 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders       
Hemoglobin  2/4 (50.00%)  2 12/16 (75.00%)  12 3/6 (50.00%)  3
Lymphopenia  0/4 (0.00%)  0 7/16 (43.75%)  7 2/6 (33.33%)  2
Platelets  3/4 (75.00%)  3 10/16 (62.50%)  10 4/6 (66.67%)  4
Edema: limb  0/4 (0.00%)  0 4/16 (25.00%)  4 0/6 (0.00%)  0
Edema: trunk/genital  0/4 (0.00%)  0 1/16 (6.25%)  1 1/6 (16.67%)  1
Cardiac disorders       
Supraventricular arrhythmia - Sinus tachycardia  0/4 (0.00%)  0 8/16 (50.00%)  8 3/6 (50.00%)  3
Ventricular arrhythmia - Ventricular tachycardia  0/4 (0.00%)  0 2/16 (12.50%)  2 1/6 (16.67%)  1
Hypertension  1/4 (25.00%)  1 1/16 (6.25%)  1 0/6 (0.00%)  0
Hypotension  2/4 (50.00%)  2 9/16 (56.25%)  9 5/6 (83.33%)  5
Gastrointestinal disorders       
Constipation  1/4 (25.00%)  1 4/16 (25.00%)  4 2/6 (33.33%)  2
Diarrhea  0/4 (0.00%)  0 6/16 (37.50%)  6 2/6 (33.33%)  2
Heartburn  0/4 (0.00%)  0 2/16 (12.50%)  2 1/6 (16.67%)  1
Mucositis  0/4 (0.00%)  0 2/16 (12.50%)  2 1/6 (16.67%)  1
Nausea  1/4 (25.00%)  1 10/16 (62.50%)  10 3/6 (50.00%)  3
Vomiting  1/4 (25.00%)  1 10/16 (62.50%)  10 1/6 (16.67%)  1
General disorders       
Fatigue  2/4 (50.00%)  2 9/16 (56.25%)  9 0/6 (0.00%)  0
Fever  4/4 (100.00%)  4 16/16 (100.00%)  16 6/6 (100.00%)  6
Insomnia  0/4 (0.00%)  0 6/16 (37.50%)  6 0/6 (0.00%)  0
Rigors/chills  2/4 (50.00%)  2 14/16 (87.50%)  14 6/6 (100.00%)  6
Weight gain  2/4 (50.00%)  2 2/16 (12.50%)  2 2/6 (33.33%)  2
Pain - Musculoskeletal  1/4 (25.00%)  1 4/16 (25.00%)  4 3/6 (50.00%)  3
Pain - Neurology  0/4 (0.00%)  0 7/16 (43.75%)  7 0/6 (0.00%)  0
Pain - Other  0/4 (0.00%)  0 2/16 (12.50%)  2 1/6 (16.67%)  1
Pain - Pulmonary  1/4 (25.00%)  1 1/16 (6.25%)  1 0/6 (0.00%)  0
Immune system disorders       
Rhinitis  1/4 (25.00%)  1 1/16 (6.25%)  1 0/6 (0.00%)  0
Infections and infestations       
Infection with normal ANC  1/4 (25.00%)  1 1/16 (6.25%)  1 0/6 (0.00%)  0
Investigations       
INR  0/4 (0.00%)  0 1/16 (6.25%)  1 1/6 (16.67%)  1
Alkaline phosphatase  1/4 (25.00%)  1 6/16 (37.50%)  6 3/6 (50.00%)  3
ALT  1/4 (25.00%)  1 2/16 (12.50%)  2 0/6 (0.00%)  0
AST  1/4 (25.00%)  1 5/16 (31.25%)  5 0/6 (0.00%)  0
Bicarbonate, serum-low  0/4 (0.00%)  0 1/16 (6.25%)  1 1/6 (16.67%)  1
Bilirubin  1/4 (25.00%)  1 4/16 (25.00%)  4 2/6 (33.33%)  2
Creatinine  0/4 (0.00%)  0 3/16 (18.75%)  3 3/6 (50.00%)  3
Hyperglycemia  0/4 (0.00%)  0 5/16 (31.25%)  5 1/6 (16.67%)  1
Hyperkalemia  0/4 (0.00%)  0 2/16 (12.50%)  2 1/6 (16.67%)  1
Hypermagnesemia  0/4 (0.00%)  0 2/16 (12.50%)  2 1/6 (16.67%)  1
Hypoalbuminemia  3/4 (75.00%)  3 16/16 (100.00%)  16 6/6 (100.00%)  6
Hypocalcemia  3/4 (75.00%)  3 12/16 (75.00%)  12 5/6 (83.33%)  5
Hypokalemia  2/4 (50.00%)  2 8/16 (50.00%)  8 1/6 (16.67%)  1
Hypomagnesemia  1/4 (25.00%)  1 6/16 (37.50%)  6 4/6 (66.67%)  4
Hyponatremia  2/4 (50.00%)  2 13/16 (81.25%)  13 4/6 (66.67%)  4
Hypophosphatemia  2/4 (50.00%)  2 15/16 (93.75%)  15 4/6 (66.67%)  4
Proteinuria  0/4 (0.00%)  0 4/16 (25.00%)  4 0/6 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  2/4 (50.00%)  2 2/16 (12.50%)  2 0/6 (0.00%)  0
Nervous system disorders       
Dizziness  0/4 (0.00%)  0 6/16 (37.50%)  6 0/6 (0.00%)  0
Mood alteration  0/4 (0.00%)  0 3/16 (18.75%)  3 0/6 (0.00%)  0
Renal and urinary disorders       
Renal - Other - Decreased urine output  0/4 (0.00%)  0 1/16 (6.25%)  1 2/6 (33.33%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  2/4 (50.00%)  2 3/16 (18.75%)  3 2/6 (33.33%)  2
Hypoxia  1/4 (25.00%)  1 0/16 (0.00%)  0 2/6 (33.33%)  2
Skin and subcutaneous tissue disorders       
Dermatology - Other  0/4 (0.00%)  0 1/16 (6.25%)  1 1/6 (16.67%)  1
Flushing  0/4 (0.00%)  0 2/16 (12.50%)  2 0/6 (0.00%)  0
Pruritus  0/4 (0.00%)  0 9/16 (56.25%)  9 4/6 (66.67%)  4
Rash/desquamation  2/4 (50.00%)  2 8/16 (50.00%)  8 2/6 (33.33%)  2
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: Hing C. Wong, Chief Clinical Officer
Organization: Altor Bioscience
Phone: 9544438600
EMail: hingwong@altorbioscience.com
Layout table for additonal information
Responsible Party: Altor BioScience
ClinicalTrials.gov Identifier: NCT00496860    
Other Study ID Numbers: CA-ALT-801-01-06
First Submitted: July 3, 2007
First Posted: July 4, 2007
Results First Submitted: April 2, 2013
Results First Posted: July 15, 2013
Last Update Posted: July 22, 2013