Trial Outcomes & Findings for AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer (NCT NCT00397878)
NCT ID: NCT00397878
Last Updated: 2019-08-20
Results Overview
Time period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.
TERMINATED
PHASE2
10 participants
Time from start of treatment to time of progression, up to 4 months
2019-08-20
Participant Flow
Recruitment Period: November 16, 2006 to April 08, 2008. Recruitment done at University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Treatment (Saracatinib)
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from start of treatment to time of progression, up to 4 monthsTime period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
7.9 weeks
Interval 2.1 to 9.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of participants who survived up to 5 years
Outcome measures
| Measure |
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
6 Participants
|
SECONDARY outcome
Timeframe: within 54 daysNumber of participants who progressed on treatment within less than or equal to 2 cycles (cycle=28 days; within 54 days PD).
Outcome measures
| Measure |
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Progression
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 weeksPopulation: No patients consented to optional tissue analysis.
Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Saracatinib)
Serious adverse events
| Measure |
Treatment (Saracatinib)
n=10 participants at risk
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Blood bilirubin increased
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Death NOS
|
60.0%
6/10 • Number of events 10 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
4/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
Other adverse events
| Measure |
Treatment (Saracatinib)
n=10 participants at risk
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
80.0%
8/10 • Number of events 12 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
5/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
60.0%
6/10 • Number of events 7 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
5/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
6/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Acidosis
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
9/10 • Number of events 12 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Cholesterol high
|
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • Number of events 8 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Creatine phosphokinase (CPK) increased
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Psychiatric disorders
Depression
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Musculoskeletal and connective tissue disorders
Extraocular muscle paresis
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Fatigue
|
100.0%
10/10 • Number of events 16 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Fever
|
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.0%
7/10 • Number of events 8 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
30.0%
3/10 • Number of events 4 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Cardiac disorders
Hypertension
|
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
2/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
60.0%
6/10 • Number of events 11 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Immune system disorders
Immune system disorders
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Infections and infestations
Urinatry Tract Infections
|
50.0%
5/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Infections and infestations
Elevated Blood Counts (Investigations)
|
50.0%
5/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 8 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
70.0%
7/10 • Number of events 7 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
40.0%
4/10 • Number of events 4 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Proctitis
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Metabolism and nutrition disorders
Proteinuria
|
50.0%
5/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
30.0%
3/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Respiratory, thoracic and mediastinal disorders
Repiratory, Running Nose
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Tumor pain
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Renal and urinary disorders
Urinary frequency/retention
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Eye disorders
Watering eyes
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
General disorders
Weight loss
|
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
10.0%
1/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
|
Additional Information
Cathy Eng, MD / Professor
University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60