Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma

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: NCT00185731
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
Damon Runyon Cancer Research Foundation
Burroughs Wellcome
Information provided by (Responsible Party):
Dean Felsher, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma, Non-Hodgkin
Intervention Drug: Atorvastatin
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atorvastatin
Hide Arm/Group Description Atorvastatin, 80mg tablet, orally once daily.
Period Title: Overall Study
Started 25
Completed 23
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Not Eligible             1
Arm/Group Title Atorvastatin
Hide Arm/Group Description Atorvastatin, 80mg tablet, orally once daily.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  84.0%
>=65 years
4
  16.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
2
   8.0%
Not Hispanic or Latino
22
  88.0%
Unknown or Not Reported
1
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
21
  84.0%
More than one race
0
   0.0%
Unknown or Not Reported
3
  12.0%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Small Lymphocytic Lymphoma
16
  64.0%
Follicular Lymphoma
6
  24.0%
Marginal Zone B-Cell Lymphoma
2
   8.0%
Splenic Marginal Zone B-Cell Lymphoma
1
   4.0%
1.Primary Outcome
Title Tumor Apoptosis
Hide Description Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants had tumors sampled for primary endpoint as per protocol. However, 1 withdrew, and only 22 of remaining participants had adequate tumor samples for analysis of apoptosis at baseline and at subsequent time points.
Arm/Group Title Atorvastatin
Hide Arm/Group Description:

Atorvastatin, 80mg tablet, was taken orally by the patient daily, beginning on study day 1.

Atorvastatin: 80 mg orally once daily

Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
7
  31.8%
2.Secondary Outcome
Title Correlation of Tumor Apoptosis to Clinical Response
Hide Description The validity of tumor apoptosis as a biologic endpoint was assessed by correlation to clinical response. A correlation substantially less than 1 is interpreted as a poor correlation, while a correlation near +1 or -1 is interpreted as a strong correlation.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
24 participants had tumors sampled for primary endpoint as per protocol. However, 1 withdrew and 1 had an inadequate tumor samples for analysis, leaving only 22 remaining participants for analysis of apoptosis at baseline and at subsequent time points.
Arm/Group Title 80 mg
Hide Arm/Group Description:

Atorvastatin, 80 mg tablet, was taken orally by the patient daily, beginning on study day 1.

Atorvastatin: 80 mg orally once daily

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Pearson Correlation Coefficient
-0.26
3.Secondary Outcome
Title Atorvastatin Toxicity
Hide Description Assessed as the number of study participants with atorvastatin-related serious adverse events (SAEs).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants who received atorvastatin
Arm/Group Title 80 mg Atorvastatin
Hide Arm/Group Description:

Atorvastatin, 80 mg tablet, was taken orally by the patient daily, beginning on study day 1.

Atorvastatin: 80 mg orally once daily

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
4
  16.7%
Time Frame [Not Specified]
Adverse Event Reporting Description 1 participant found not to be eligible and was not analyzed
 
Arm/Group Title Atorvastatin
Hide Arm/Group Description Atorvastatin, 80mg tablet, orally once daily.
All-Cause Mortality
Atorvastatin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Atorvastatin
Affected / at Risk (%)
Total   4/24 (16.67%) 
Gastrointestinal disorders   
Diarrhoea  1  1/24 (4.17%) 
General disorders   
Pain - Abdominal NOS  1  1/24 (4.17%) 
Hepatobiliary disorders   
Cholecystitis  1  1/24 (4.17%) 
Psychiatric disorders   
Mood alteration - Anxiety  1  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin
Affected / at Risk (%)
Total   24/24 (100.00%) 
Blood and lymphatic system disorders   
low platelets  1  1/24 (4.17%) 
elevated platelets  1  1/24 (4.17%) 
bruising  1  1/24 (4.17%) 
Cardiac disorders   
palpitation  1  1/24 (4.17%) 
Gastrointestinal disorders   
nausea  1  3/24 (12.50%) 
constipation  1  2/24 (8.33%) 
diarrhea  1  4/24 (16.67%) 
anorexia  1  1/24 (4.17%) 
bloating  1  1/24 (4.17%) 
vomiting  1  1/24 (4.17%) 
General disorders   
diaphoresis  1 [1]  1/24 (4.17%) 
pain  1 [2]  13/24 (54.17%) 
fatigue  1  1/24 (4.17%) 
Hepatobiliary disorders   
elevated SGOT (serum glutamic oxaloacetic transaminase)  1  5/24 (20.83%) 
elevated SGPT (serum glutamic pyruvic transaminase)  1  6/24 (25.00%) 
elevated alk phos (alkaline phosphatase)  1  3/24 (12.50%) 
hyperbilirubinemia  1  2/24 (8.33%) 
Infections and infestations   
infection  1 [3]  4/24 (16.67%) 
Musculoskeletal and connective tissue disorders   
hematoma  1  2/24 (8.33%) 
Vascular disorders   
vasculitis  1  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
night sweats (1)
[2]
myalgia (2), pain NOS (2), leg cramps (2), back pain (1), leg pain (1), right upper quadrant pain (1), toe pain (1), abdominal pain (1), headache (1), neurologic pain (1)
[3]
(upper respiratory)
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
Layout table for Results Point of Contact information
Name/Title: Alice Fan, MD
Organization: Stanford University School of Medicine
Phone: 650-725-6454
EMail: afan@stanford.edu
Layout table for additonal information
Responsible Party: Dean Felsher, Stanford University
ClinicalTrials.gov Identifier: NCT00185731    
Other Study ID Numbers: IRB-13683
4328-07 ( Other Identifier: Damon Runyon Cancer Research Foundation )
95140 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LYMNHL0020 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: January 24, 2017
Results First Posted: December 2, 2017
Last Update Posted: December 2, 2017