Trial Outcomes & Findings for Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma (NCT NCT00185731)
NCT ID: NCT00185731
Last Updated: 2017-12-02
Results Overview
Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 year
Results posted on
2017-12-02
Participant Flow
Participant milestones
| Measure |
Atorvastatin
Atorvastatin, 80mg tablet, orally once daily.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Atorvastatin
Atorvastatin, 80mg tablet, orally once daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not Eligible
|
1
|
Baseline Characteristics
Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=25 Participants
Atorvastatin, 80mg tablet, orally once daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Histology
Small Lymphocytic Lymphoma
|
16 Participants
n=5 Participants
|
|
Histology
Follicular Lymphoma
|
6 Participants
n=5 Participants
|
|
Histology
Marginal Zone B-Cell Lymphoma
|
2 Participants
n=5 Participants
|
|
Histology
Splenic Marginal Zone B-Cell Lymphoma
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
Outcome measures
| Measure |
Atorvastatin
n=22 Participants
Atorvastatin, 80mg tablet, was taken orally by the patient daily, beginning on study day 1.
Atorvastatin: 80 mg orally once daily
|
|---|---|
|
Tumor Apoptosis
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Atorvastatin
n=22 Participants
Atorvastatin, 80mg tablet, was taken orally by the patient daily, beginning on study day 1.
Atorvastatin: 80 mg orally once daily
|
|---|---|
|
Correlation of Tumor Apoptosis to Clinical Response
|
-0.26 Pearson Correlation Coefficient
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All study participants who received atorvastatin
Assessed as the number of study participants with atorvastatin-related serious adverse events (SAEs).
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Atorvastatin, 80mg tablet, was taken orally by the patient daily, beginning on study day 1.
Atorvastatin: 80 mg orally once daily
|
|---|---|
|
Atorvastatin Toxicity
|
4 Participants
|
Adverse Events
Atorvastatin
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=24 participants at risk
Atorvastatin, 80mg tablet, orally once daily.
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
General disorders
Pain - Abdominal NOS
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
Other adverse events
| Measure |
Atorvastatin
n=24 participants at risk
Atorvastatin, 80mg tablet, orally once daily.
|
|---|---|
|
Hepatobiliary disorders
elevated SGOT (serum glutamic oxaloacetic transaminase)
|
20.8%
5/24
1 participant found not to be eligible and was not analyzed
|
|
Hepatobiliary disorders
elevated SGPT (serum glutamic pyruvic transaminase)
|
25.0%
6/24
1 participant found not to be eligible and was not analyzed
|
|
Hepatobiliary disorders
elevated alk phos (alkaline phosphatase)
|
12.5%
3/24
1 participant found not to be eligible and was not analyzed
|
|
Infections and infestations
infection
|
16.7%
4/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
nausea
|
12.5%
3/24
1 participant found not to be eligible and was not analyzed
|
|
Musculoskeletal and connective tissue disorders
hematoma
|
8.3%
2/24
1 participant found not to be eligible and was not analyzed
|
|
Blood and lymphatic system disorders
low platelets
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Blood and lymphatic system disorders
elevated platelets
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
constipation
|
8.3%
2/24
1 participant found not to be eligible and was not analyzed
|
|
General disorders
diaphoresis
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
General disorders
pain
|
54.2%
13/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
4/24
1 participant found not to be eligible and was not analyzed
|
|
General disorders
fatigue
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
8.3%
2/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
anorexia
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
bloating
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Cardiac disorders
palpitation
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Gastrointestinal disorders
vomiting
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Vascular disorders
vasculitis
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
|
Blood and lymphatic system disorders
bruising
|
4.2%
1/24
1 participant found not to be eligible and was not analyzed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place